Closed-loop therapy stimulation response to patient adjustment

ABSTRACT

A medical device with closed-loop responsive stimulation may include techniques to mitigate the impact on the therapy output of noise coupled into the medical device. A medical device according to this disclosure may determine the presence of noise and alter the closed loop policy to provide the necessary therapy to the patient and avoid prolonged under stimulation caused by the noise. The medical device may continue therapy, while testing for noise. When the device determines the noise level no longer affects the output therapy, the device may return the closed loop policy to a no-noise mode of operation. The medical device may also include techniques to mitigate the impact of manual adjustment while the medical device is subject to noise or is responding to changes in the patient&#39;s physiological signals.

TECHNICAL FIELD

This disclosure generally relates to electrical stimulation therapy, andmore specifically, control of electrical stimulation therapy.

BACKGROUND

Medical devices may be external or implanted and may be used to deliverelectrical stimulation therapy to patients via various tissue sites totreat a variety of symptoms or conditions such as chronic pain, tremor,Parkinson's disease, epilepsy, urinary or fecal incontinence, sexualdysfunction, obesity, or gastroparesis. A medical device may deliverelectrical stimulation therapy via one or more leads that includeelectrodes located proximate to target locations associated with thebrain, the spinal cord, pelvic nerves, peripheral nerves, or thegastrointestinal tract of a patient. Stimulation proximate the spinalcord, proximate the sacral nerve, within the brain, and proximateperipheral nerves are often referred to as spinal cord stimulation(SCS), sacral neuromodulation (SNM), deep brain stimulation (DBS), andperipheral nerve stimulation (PNS), respectively.

SUMMARY

In general, the disclosure describes techniques for implementingclosed-loop responsive stimulation in which a medical device may adjusttherapy output based on sensed signals. A medical device according tothis disclosure may implement techniques to mitigate the impact on thetherapy output of noise coupled into the medical device. A medicaldevice according to this disclosure also may implement techniques tomitigate the impact of manual adjustment while the medical device issubject to noise or is responding to changes in the patient'sphysiological signals.

In one example, this disclosure describes a method includes receivinginformation indicative of a sensed evoked compound action potential(ECAP) signal; determining a value of a characteristic of the ECAPsignal based on the information, wherein the ECAP signal is elicited bya respective stimulation pulse of a plurality of stimulation pulses;executing a closed loop policy that adjusts, based on the value of thecharacteristic of the ECAP signal, a value of a parameter that at leastpartially defines stimulation therapy; determining that the value of thecharacteristic of the ECAP signal is outside of an expected range; andresponsive to determining that the value of the characteristic of theECAP signal is outside of the expected range, disabling the closed looppolicy.

In another example, this disclosure describes a medical devicecomprising processing circuitry configured to: receive informationindicative of a sensed evoked compound action potential (ECAP) signaldetermine a value of a characteristic of the ECAP signal based on theinformation, wherein the ECAP signal is elicited by respectivestimulation pulses of a plurality of pulses; determine whether a valueof a characteristic of the ECAP signal is outside of an expected range;execute a closed loop policy, wherein the closed loop policy adjusts avalue of a parameter that at least partially defines stimulationtherapy, based on the value of the characteristic of the ECAP signal;and responsive to determining that the value of the characteristic ofthe ECAP signal is outside of the expected range, disable theclosed-loop policy.

In another example, this disclosure describes a computer-readable mediumcomprising instructions for causing programmable processor processingcircuitry to: receive information indicative of a sensed evoked compoundaction potential (ECAP) signal determine a value of a characteristic ofthe ECAP signal based on the information, wherein the ECAP signal iselicited by respective stimulation pulses of a plurality of pulses;determine whether a value of a characteristic of the ECAP signal isoutside of an expected range; execute a closed loop policy, wherein theclosed loop policy adjusts a value of a parameter that at leastpartially defines stimulation therapy, based on the value of thecharacteristic of the ECAP signal; and responsive to determining thatthe value of the characteristic of the ECAP signal is outside of theexpected range, disable the closed-loop policy.

In one example, this disclosure describes a method includes delivering,by stimulation generation circuitry of a medical device, electricalstimulation therapy to a patient, the electrical stimulation therapycomprising a plurality of pulses defined by a set of parameters;receiving, by processing circuitry of the medical device, a command froman external programmer to change a value of a parameter defining theplurality of pulses, wherein the external programmer is external to themedical device; determining, by the processing circuitry, that therequested change to the parameter is a request to increase the value ofthe parameter defining the plurality of pulses; determining, by theprocessing circuitry, that a control policy executed by the processingcircuitry is determining values of the parameter that defines theelectrical stimulation therapy; responsive to determining that thecontrol policy is determining values of the parameter that defines theelectrical stimulation therapy, rejecting, by the processing circuitry,the request to change the value of the parameter.

In another example, this disclosure describes a medical device includesstimulation generation circuitry configured to deliver electricalstimulation therapy to a patient, the electrical stimulation therapycomprising a plurality of pulses defined by a set of parameters; andprocessing circuitry configured to: receive a command from an externalprogrammer (1602) to change a value of a parameter defining theplurality of pulses, wherein the external programmer is external to themedical device; determine that the requested change to the parameter isa request to increase the value of the parameter defining the pluralityof pulses; determining that a control policy executed by the processingcircuitry is determining values of the parameter that defines theelectrical stimulation therapy responsive to determining that thecontrol policy is determining values of the parameter that defines theelectrical stimulation therapy, reject the request to change the valueof the parameter.

In another example, this disclosure describes a computer-readable mediumcomprising instructions for causing a programmable processor of amedical device to: cause stimulation generation circuitry of the medicaldevice to deliver electrical stimulation therapy to a patient, theelectrical stimulation therapy comprising a plurality of pulses definedby a set of parameters; receive of the medical device, a command from anexternal programmer to change a value of a parameter defining theplurality of pulses, wherein the external programmer is external to themedical device; determine that the requested change to the parameter isa request to increase the value of the parameter defining the pluralityof pulses; determine that a control policy executed by the processingcircuitry is determining values of the parameter that defines theelectrical stimulation therapy; responsive to determining that thecontrol policy is determining values of at the parameter that definesthe electrical stimulation therapy, reject the request to change thevalue of the parameter.

The details of one or more examples of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the disclosure will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram illustrating an example system thatincludes an implantable medical device (IMD) configured to deliverspinal cord stimulation (SCS) therapy and an external programmer, inaccordance with one or more techniques of this disclosure.

FIG. 2 is a block diagram illustrating an example configuration ofcomponents of the IMD of FIG. 1 , in accordance with one or moretechniques of this disclosure.

FIG. 3 is a block diagram illustrating an example configuration ofcomponents of the external programmer of FIG. 1 , in accordance with oneor more techniques of this disclosure.

FIG. 4 is a graph of example evoked compound action potentials (ECAPs)sensed for respective stimulation pulses, in accordance with one or moretechniques of this disclosure.

FIG. 5 is an example timing diagram illustrating an example ofelectrical stimulation pulses, respective stimulation signals, andrespective sensed ECAPs, in accordance with one or more techniques ofthis disclosure.

FIG. 6 is a timing diagram illustrating an example closed loop responseto a sensed ECAP that is outside of a predetermined range, in accordancewith one or more techniques of this disclosure.

FIG. 7 is a timing diagram illustrating an example technique forsuspending a closed loop algorithm, in accordance with one or moretechniques of this disclosure.

FIG. 8 is a timing diagram illustrating an example medical deviceproviding electrical stimulation while suspending a closed loopalgorithm, in accordance with one or more techniques of this disclosure.

FIG. 9 is a timing diagram illustrating an example of recovering asuspended closed-loop algorithm, in accordance with one or moretechniques of this disclosure.

FIG. 10 is a flow diagram illustrating an example operation forsuspending and recovering a suspended closed-loop algorithm, inaccordance with one or more techniques of this disclosure.

FIG. 11 is a timing diagram illustrating an example of a medical deviceproviding electrical stimulation while suspending a closed loopalgorithm, in accordance with one or more techniques of this disclosure.

FIG. 12 is a timing diagram illustrating an example of a medical devicesensing noise abatement while suspending a closed loop algorithm, inaccordance with one or more techniques of this disclosure.

FIG. 13 is a timing diagram illustrating an example of re-starting asuspended closed-loop algorithm, in accordance with one or moretechniques of this disclosure.

FIG. 14 is a timing diagram illustrating an example of an attemptedrecovery for a suspended closed-loop algorithm, in accordance with oneor more techniques of this disclosure.

FIG. 15 is a flow diagram illustrating an example operation forsuspending and recovering a suspended closed-loop algorithm, inaccordance with one or more techniques of this disclosure.

FIG. 16 is a flow chart illustrating an example operation for managingpatient input while delivering electrical stimulation therapy, inaccordance with one or more techniques of this disclosure.

DETAILED DESCRIPTION

The disclosure describes techniques for implementing closed-loopresponsive stimulation in which a medical device may adjust therapyoutput based on sensed signals. A medical device according to thisdisclosure may include techniques to mitigate the impact on the therapyoutput of noise coupled into the medical device.

In some examples, a closed-loop responsive medical device may controlelectrical stimulation therapy by sensing an evoked compound actionpotential (ECAP). An ECAPS Responsive Stimulation (ERS) therapy basedmedical device may be configured to modulate therapy output (e.g.,control and adjust one or more parameter values that define therapy) inresponse to measured ECAPS. Therapy output may be in the form of anelectrical stimulation pulse, such as a voltage pulse or a currentpulse, defined by a set of therapy parameters, e.g. stimulationamplitude, frequency, pulse width, pulse shape and other parameters. Forexample, in response to determining that a characteristic of themeasured ECAP signal (e.g., a voltage amplitude) has deviated from atarget ECAP characteristic, the system may change the values of one ormore stimulation parameters of the next one or more output pulsesdelivered to the patient. For example, the system may increase ordecrease a current amplitude or a pulse width of the output electricalstimulation pulse.

In some examples, changes in patient physiology, such as changes inhydration level, patient response to a virus, changes in drug therapy,activity level and many other factors may cause a given output pulse toresult in a different measured ECAP. Also, changes in patient posturemay change a distance between an implanted electrode and a target nerve.For example, as a patient moves between a supine posture state to astanding posture state or when a patient coughs or sneezes may changerelative location of one or more electrodes and a target nerve. An ERStherapy based medical device may include a closed-loop algorithm toreduce the device stimulation output when high ECAP signals are measuredto prevent over-stimulation and may lead to patient discomfort. When thesensed ECAP signals reduce, the closed-loop ERS algorithm may return themedical device output settings to default values.

However, a closed-loop responsive medical device may be susceptible tonoise, such as external noise that may be coupled into the sensingsystem that the medical device employs for feedback into closed-loopcontrol. The noise may adversely impact the ability of the medicaldevice to appropriately detect the ECAP signal from patient tissues,such as the system sensing the amplitude of the noise when it is greaterthan the ECAP signals themselves. In response to the detected noise, thesystem may respond by reducing stimulation to the patient. Reducedstimulation can lead to under stimulation and resulting patientdiscomfort from untreated symptoms. In some examples, the patient mayhave an adjustment tool (e.g., an external programmer) configured tocommunicate with the medical device to increase or decrease therapyintensity based on the patient's perceived response to the therapyprovided by the medical device. A patient may manually increase thedefault stimulation level using the adjustment tool. In examples inwhich the patient manually adjusts the default stimulation level whilethe medical device is reducing stimulation intensity because of thepresence of noise, or the medical device is adapting to changes in thepatient's physiological signals, when the noise is removed, or when thephysiological signals change again, the new default stimulationparameter values may cause the system to deliver inappropriatestimulation (over or under stimulation) resulting in patient discomfort.A medical device according to this disclosure may include techniques tomitigate the impact of noise on the therapy output and mitigate theimpact of manual adjustment while the medical device is subject to noiseor is responding to changes in the patient's physiological signals.Also, a medical device according to this disclosure may determine thepresence of noise and alter the closed-loop algorithm to provide thenecessary therapy to the patient and avoid prolonged under stimulationcaused by the noise.

The term “stimulation signal” may be used herein to describe a signalthat the medical device senses that represents a stimulation pulsedelivered by the medical device. This stimulation signal may also bereferred to as an “artifact” in the sensed signals. One or more senseelectrodes of the medical device may detect a stimulation signal due toone or more stimulation electrodes proximate to the sense electrodesdelivering a stimulation pulse. In this way, delivering a stimulationpulse may cause the medical device to sense a respective stimulationsignal during a window of time substantially overlapping with thedelivery of the stimulation pulse. An electrical potential of thestimulation electrodes during the window of time in which the medicaldevice delivers the stimulation pulse may cause the sensing circuitry ofthe medical device to generate a sense signal which is representative ofthe stimulation pulse delivered during the window of time. Thestimulation signal is thus representative of electrical potentialchanges in tissue directly caused by the delivered stimulation pulse.Conversely, an ECAP is a signal representative of physiological action(e.g., depolarizing nerve fibers) caused by the stimulation pulse. Inthis way, stimulation signals may be at least partially distinguishedfrom ECAPs, since ECAPs represent electrical signals sensed by themedical device due to an excitation of target tissue of the patient inresponse to the delivery of a stimulation pulse. In other words, an ECAPrepresents a detected physiological response to a stimulation pulse, anda stimulation signal represents the direct detection of the stimulationpulse itself and associated changes in the charge in tissue.

In some examples, the medical device may deliver stimulation pulses inthe form of control pulses and informed pulses. More specifically,electrical stimulation pulses are delivered in the form of informedpulses and control pulses that are at least partially interleaved witheach other. Control pulses (e.g., stimulation signal test pulses) arethose stimulation pulses that are configured to elicit one or both of astimulation signal and a detectable ECAP signal. In some examples,control pulses may contribute to the therapy for a patient. In otherexamples, control pulses do not contribute to the therapy for thepatient, e.g., non-therapeutic pulses. In this manner, control pulsesmay or may not be configured to elicit a therapeutic effect for thepatient. Informed pulses are those stimulation pulses that are at leastpartially defined by one or more parameters based on the detectablestimulation signal elicited from one or more control pulses. In someexamples, one or more informed pulses are at least partially defined byone or more parameters based on a respective ECAP elicited from one ormore control pulses. In this manner, the informed pulses are “informed”by the ECAP signal detected from a control pulse. Informed pulses arealso configured to provide a therapy to a patient, such as paresthesiathat relieves pain symptoms.

As described herein, a medical device may be configured to deliver aplurality of informed pulses and/or control pulses configured to providea therapy to the patient based on one or more parameters of ECAP signalselicited by previously delivered control pulses. The medical device, insome cases, may deliver a plurality of informed pulses, which areconfigured to provide or at least contribute to a therapy to the patientbased on one or more parameters of ECAP signals elicited by controlpulses. In some examples, the control pulses may be configured to elicitECAP signals without contributing to the therapy of the patient.However, in other examples, the control pulses may provide therapy tothe patient either alone or in combination with the informed pulses. Thecontrol pulses may be interleaved with the delivery of the informedpulses. For example, the medical device may alternate the delivery ofinformed pulses with control pulses such that a control pulse isdelivered, and an ECAP signal is sensed from the control pulses, betweenconsecutive informed pulses. In some examples, multiple control pulsesare delivered, and respective ECAP signals sensed, between the deliveryof consecutive informed pulses.

In some examples, multiple informed pulses will be delivered betweenconsecutive control pulses. In any case, the informed pulses may bedelivered according to a predetermined pulse frequency selected so thatthe informed pulses can produce or contribute to a therapeutic resultfor the patient. One or more control pulses are then delivered, and therespective ECAP signals sensed, within one or more time windows betweenconsecutive informed pulses delivered according to the predeterminedpulse frequency. The predetermined pulse frequency may be a singleconsistent frequency or a varied frequency that varies over time. Thepulse width of the control pulses may be shorter than the pulse width ofthe informed pulses to enable the medical device to detect the ECAPsignals elicited from the control pulses. Put another way, the longerpulse width of the informed pulses may prevent all phases of theresulting stimulation signals and prevent the resulting ECAP signalsfrom being detected due to, for example, overlapping of the informedpulse with the ECAP signal and the stimulation signal. In this manner, amedical device can administer informed pulses from the medical deviceuninterrupted while one or both of ECAPs and stimulation signals can besensed from control pulses delivered during times at which the informedpulses are not being delivered.

In some examples, a pulse frequency of stimulation pulses (e.g., controlpulses and/or informed pules) delivered by the medical device may bewithin a range from 50 Hertz (Hz) to 70 Hz, but this is not required. Insome examples, a pulse frequency of stimulation pulses (e.g., controlpulses and/or informed pules) delivered by the medical device may bewithin a range from 0.1 Hz to 100 kilohertz (KHz), The pulse frequencyof the stimulation pulses may be within a range from 0.5 KHz to 5 KHz(e.g., 1 KHz) and/or within a range from 5 KHz to 15 KHz (e.g., 10 KHz),as examples. In some examples, when a frequency of control pulses andinformed pulses increases, a maximum pulse width of control pulses whichdo not obscure respective control pulses decreases. These ranges arejust examples. In some examples, both control and informed pulses can bedelivered over a wide range of frequencies and informed pulses may beinterspersed between multiple control pulses.

Although electrical stimulation is generally described herein in theform of electrical stimulation pulses, electrical stimulation may bedelivered in non-pulse form in other examples. For example, electricalstimulation may be delivered as a signal having various waveform shapes,frequencies, and amplitudes. Therefore, electrical stimulation in theform of a non-pulse signal may be a continuous signal than may have asinusoidal waveform or other continuous waveform.

FIG. 1 is a conceptual diagram illustrating an example system thatincludes an implantable medical device (IMD) configured to deliverspinal cord stimulation (SCS) therapy and an external programmer, inaccordance with one or more techniques of this disclosure. Although thetechniques described in this disclosure are generally applicable to avariety of medical devices including external devices and IMDs,application of such techniques to IMDs and, more particularly,implantable electrical stimulators (e.g., neurostimulators) will bedescribed for purposes of illustration. The disclosure will refer to animplantable SCS system for purposes of illustration, but the techniquesdescribed may also apply, without limitation, to other types of medicaldevices or other therapeutic applications of medical devices.

As shown in FIG. 1 , system 100 includes an IMD 110, leads 130A and130B, and external programmer 150 shown in conjunction with a patient105, who is ordinarily a human patient. In the example of FIG. 1 , IMD110 is an implantable electrical stimulator that is configured togenerate and deliver electrical stimulation therapy to patient 105 viaone or more electrodes of electrodes of leads 130A and/or 130B(collectively, “leads 130”), e.g., for relief of chronic pain or othersymptoms. In other examples, IMD 110 may be coupled to a single leadcarrying multiple electrodes or more than two leads each carryingmultiple electrodes. This electrical stimulation may be delivered in theform of stimulation pulses. In some examples, IMD 110 may be configuredto generate and deliver stimulation pulses to include control pulsesconfigured to elicit ECAP signals. The control pulses may or may notcontribute to therapy in some examples. In some examples, IMD 110 may,in addition to control pulses, deliver informed pulses that contributeto the therapy for the patient, but which do not elicit detectableECAPs. IMD 110 may be a chronic electrical stimulator that remainsimplanted within patient 105 for weeks, months, or even years. In otherexamples, IMD 110 may be a temporary, or trial, stimulator used toscreen or evaluate the efficacy of electrical stimulation for chronictherapy. In one example, IMD 110 is implanted within patient 105, whilein another example, IMD 110 is an external device coupled topercutaneously implanted leads. In some examples, IMD 110 uses one ormore leads, while in other examples, IMD 110 is leadless.

IMD 110 may be constructed of any polymer, metal, or composite materialsufficient to house the components of IMD 110 (e.g., componentsillustrated in FIG. 2 ) within patient 105. In this example, IMD 110 maybe constructed with a biocompatible housing, such as titanium orstainless steel, or a polymeric material such as silicone, polyurethane,or a liquid crystal polymer, and surgically implanted at a site inpatient 105 near the pelvis, abdomen, or buttocks. In other examples,IMD 110 may be implanted within other suitable sites within patient 105,which may depend, for example, on the target site within patient 105 forthe delivery of electrical stimulation therapy. The outer housing of IMD110 may be configured to provide a hermetic seal for components, such asa rechargeable or non-rechargeable power source. In addition, in someexamples, the outer housing of IMD 110 is selected from a material thatfacilitates receiving energy to charge the rechargeable power source.

Electrical stimulation energy, which may be, for example, constantcurrent or constant voltage-based pulses may be delivered from IMD 110to one or more target tissue sites of patient 105 via one or moreelectrodes (not shown) of implantable leads 130. In the example of FIG.1 , leads 130 carry electrodes that are placed adjacent to the targettissue of spinal cord 120. One or more of the electrodes may be disposedat a distal tip of a leads 130 and/or at other positions at intermediatepoints along the lead. Leads 130 may be implanted and coupled to IMD110. The electrodes may transfer electrical stimulation generated by anelectrical stimulation generator in IMD 110 to tissue of patient 105.Although leads 130 may each be a single lead, leads 130 may include alead extension or other segments that may aid in implantation orpositioning of leads 130. In some other examples, IMD 110 may be aleadless stimulator with one or more arrays of electrodes arranged on ahousing of the stimulator rather than leads that extend from thehousing. In addition, in some other examples, system 100 may include onelead or more than two leads, each coupled to IMD 110 and directed tosimilar or different target tissue sites.

The electrodes of leads 130 may be electrode pads on a paddle lead,circular (e.g., ring) electrodes surrounding the body of the lead,conformable electrodes, cuff electrodes, segmented electrodes (e.g.,electrodes disposed at different circumferential positions around thelead instead of a continuous ring electrode), any combination thereof(e.g., ring electrodes and segmented electrodes) or any other type ofelectrodes capable of forming unipolar, bipolar or multipolar electrodecombinations for therapy. Ring electrodes arranged at different axialpositions at the distal ends of lead 130 will be described for purposesof illustration.

The deployment of electrodes via leads 130 is described for purposes ofillustration, but arrays of electrodes may be deployed in differentways. For example, a housing associated with a leadless stimulator maycarry arrays of electrodes, e.g., rows and/or columns (or otherpatterns), to which shifting operations may be applied. Such electrodesmay be arranged as surface electrodes, ring electrodes, or protrusions.As a further alternative, electrode arrays may be formed by rows and/orcolumns of electrodes on one or more paddle leads. In some examples,electrode arrays include electrode segments, which are arranged atrespective positions around a periphery of a lead, e.g., arranged in theform of one or more segmented rings around a circumference of acylindrical lead. In other examples, one or more of leads 130 are linearleads having 8 ring electrodes along the axial length of the lead. Inanother example, the electrodes are segmented rings arranged in a linearfashion along the axial length of the lead and at the periphery of thelead.

The stimulation parameter of a therapy stimulation program that definesthe stimulation pulses of electrical stimulation therapy by IMD 110through the electrodes of leads 130 may include information identifyingwhich electrodes have been selected for delivery of stimulationaccording to a stimulation program, the polarities of the selectedelectrodes, i.e., the electrode combination for the program, and voltageor current amplitude, pulse frequency, pulse width, pulse shape ofstimulation delivered by the electrodes. These stimulation parameters ofstimulation pulses (e.g., control pulses and/or informed pulses) aretypically predetermined parameter values determined prior to delivery ofthe stimulation pulses (e.g., set according to a stimulation program).However, in some examples, system 100 changes one or more parametervalues automatically based on one or more factors or based on userinput.

A test stimulation program may define stimulation parameter values thatdefine control pulses delivered by IMD 110 through at least some of theelectrodes of leads 130. These stimulation parameter values may includeinformation identifying which electrodes have been selected for deliveryof control pulses, the polarities of the selected electrodes, i.e., theelectrode combination for the test stimulation program, and voltage orcurrent amplitude, pulse frequency, pulse width, and pulse shape ofstimulation delivered by the electrodes. The stimulation signals (e.g.,one or more stimulation pulses or a continuous stimulation waveform)defined by the parameters of each test stimulation program areconfigured to evoke a compound action potential from nerves. In someexamples, the test stimulation program defines when the control pulsesare to be delivered to the patient based on the frequency and/or pulsewidth of the informed pulses when informed pulse are also delivered. Insome examples, the stimulation defined by each test stimulation programare not intended to provide or contribute to therapy for the patient. Inother examples, the stimulation defined by each test stimulation programmay contribute to therapy when the control pulses elicit one or both ofdetectable ECAP signals. In this manner, the test stimulation programmay define stimulation parameters the same or similar to the stimulationparameters of therapy stimulation programs.

Although FIG. 1 is directed to SCS therapy, e.g., used to treat pain, inother examples system 100 may be configured to treat any other conditionthat may benefit from electrical stimulation therapy. For example,system 100 may be used to treat tremor, Parkinson's disease, epilepsy, apelvic floor disorder (e.g., urinary incontinence or other bladderdysfunction, fecal incontinence, pelvic pain, bowel dysfunction, orsexual dysfunction), obesity, gastroparesis, or psychiatric disorders(e.g., depression, mania, obsessive compulsive disorder, anxietydisorders, and the like). In this manner, system 100 may be configuredto provide therapy taking the form of deep brain stimulation (DBS),peripheral nerve stimulation (PNS), peripheral nerve field stimulation(PNFS), cortical stimulation (CS), pelvic floor stimulation,gastrointestinal stimulation, or any other stimulation therapy capableof treating a condition of patient 105.

In some examples, leads 130 includes one or more sensors configured toallow IMD 110 to monitor one or more parameters of patient 105, such aspatient activity, pressure, temperature, posture, or othercharacteristics. The one or more sensors may be provided in addition to,or in place of, therapy delivery by leads 130.

IMD 110 is configured to deliver electrical stimulation therapy topatient 105 via selected combinations of electrodes carried by one orboth of leads 130, alone or in combination with an electrode carried byor defined by an outer housing of IMD 110. The target tissue for theelectrical stimulation therapy may be any tissue affected by electricalstimulation, which may be in the form of electrical stimulation pulsesor continuous waveforms. In some examples, the target tissue includesnerves, smooth muscle, or skeletal muscle. In the example illustrated byFIG. 1 , the target tissue is tissue proximate spinal cord 120, such aswithin an intrathecal space or epidural space of spinal cord 120, or, insome examples, adjacent nerves that branch off spinal cord 120. Leads130 may be introduced into spinal cord 120 in via any suitable region,such as the thoracic, cervical, or lumbar regions. Stimulation of spinalcord 120 may, for example, prevent pain signals from traveling throughspinal cord 120 and to the brain of patient 105. Patient 105 mayperceive the interruption of pain signals as a reduction in pain and,therefore, efficacious therapy results. In other examples, stimulationof spinal cord 120 may produce paresthesia which may be reduce theperception of pain by patient 105, and thus, provide efficacious therapyresults.

IMD 110 generates and delivers electrical stimulation therapy to atarget stimulation site within patient 105 via the electrodes of leads130 to patient 105 according to one or more therapy stimulationprograms. A therapy stimulation program defines values for one or moreparameters that define an aspect of the therapy delivered by IMD 110according to that program. For example, a therapy stimulation programthat controls delivery of stimulation by IMD 110 in the form of pulsesmay define values for voltage or current pulse amplitude, pulse width,pulse shape, and pulse rate (e.g., pulse frequency) for stimulationpulses delivered by IMD 110 according to that program.

In some examples where relevant phases of stimulation signals cannot bedetected from the types of pulses intended to be delivered to providetherapy to the patient, control pulses and informed pulses may bedelivered. For example, IMD 110 is configured to deliver controlstimulation in the form of control pulses to patient 105 via acombination of electrodes of leads 130, alone or in combination with anelectrode carried by or defined by an outer housing of IMD 110. Thetissue targeted by the control stimulation may be the same tissuetargeted by the electrical stimulation therapy, delivered in the form ofinformed pulses. But IMD 110 may deliver control stimulation pulses viathe same, at least some of the same, or different electrodes. Sincecontrol stimulation pulses are delivered in an interleaved manner withinformed pulses, a clinician and/or user may select any desiredelectrode combination for informed pulses. Like the electricalstimulation therapy, the control stimulation may be in the form ofelectrical stimulation pulses or continuous waveforms.

In one example, each control stimulation pulse may include a balanced,bi-phasic square pulse that employs an active recharge phase. However,in other examples, the control stimulation pulses may include amonophasic pulse followed by a passive recharge phase. In otherexamples, a control pulse may include an imbalanced bi-phasic portionand a passive recharge portion. In other examples, a control stimulationpulse may include a tri-phasic pulse or pulse having more than threephases. Although not necessary, a bi-phasic control pulse may include aninterphase interval between the positive and negative phase to promotepropagation of the nerve impulse in response to the first phase of thebi-phasic pulse. The control stimulation may be delivered withoutinterrupting the delivery of the electrical stimulation informed pulses,such as during the window between consecutive informed pulses. In somecases, the control pulses may elicit an ECAP signal from the tissue, andIMD 110 may sense the ECAP signal via two or more electrodes on leads130. In cases where the control stimulation pulses are applied to spinalcord 120, the signal may be sensed by IMD 110 from spinal cord 120.

IMD 110 may deliver control stimulation to a target stimulation sitewithin patient 105 via the electrodes of leads 130 according to one ormore test stimulation programs. The one or more test stimulationprograms may be stored in a storage device of IMD 110. Each test programof the one or more test stimulation programs includes values for one ormore parameters that define an aspect of the control stimulationdelivered by IMD 110 according to each respective test program, such ascurrent or voltage amplitude, pulse width, pulse frequency, electrodecombination, and, in some examples, timing based on informed pulses tobe delivered to patient 105. In some examples, IMD 110 delivers controlstimulation to patient 105 according to multiple test stimulationprograms.

A user, such as a clinician (not shown in FIG. 1 ) or patient 105, mayinteract with a user interface (not shown in FIG. 1 ) of externalprogrammer 150 to program IMD 110. Programming of IMD 110 may refergenerally to the generation and transfer of commands, programs, or otherinformation to control the operation of IMD 110. In this manner, IMD 110may receive the transferred commands and programs from externalprogrammer 150 to control electrical stimulation therapy (e.g., informedpulses) and control stimulation (e.g., control pulses). For example,external programmer 150 may transmit therapy stimulation programs, teststimulation programs, stimulation parameter adjustments, therapystimulation program selections, test program selections, user input, orother information to control the operation of IMD 110, e.g., by wirelesstelemetry or wired connection. As described herein, stimulationdelivered to the patient may include control pulses, and, in someexamples, stimulation may include control pulses and informed pulses.

In some cases, external programmer 150 may be called a physician orclinician programmer if it is primarily intended for use by a physicianor clinician. In other cases, external programmer 150 may becharacterized as a patient programmer if it is primarily intended foruse by a patient. A patient programmer may be generally accessible topatient 105 and, in many cases, may be a portable device that mayaccompany patient 105 throughout the patient's daily routine. Forexample, a patient programmer may receive input from patient 105 whenthe patient wishes to terminate or change electrical stimulationtherapy. In general, a physician or clinician programmer may supportselection and generation of programs by a clinician for use by IMD 110,whereas a patient programmer may support adjustment and selection ofsuch programs by a patient during ordinary use. In other examples,external programmer 150 may include, or be part of, an external chargingdevice that recharges a power source of IMD 110. In this manner, a usermay program and charge IMD 110 using one device, or multiple devices.

As described herein, information may be transmitted between externalprogrammer 150 and IMD 110. Therefore, IMD 110 and external programmer150 may communicate via wireless communication using any techniquesknown in the art. Examples of communication techniques may include, forexample, radiofrequency (RF) telemetry and inductive coupling, but othertechniques are also contemplated. In some examples, external programmer150 includes a communication head that may be placed proximate to thepatient's body near the IMD 110 implant site to improve the quality orsecurity of communication between IMD 110 and external programmer 150.

Communication between external programmer 150 and IMD 110 may occurduring power transmission or separate from power transmission.

In some examples, IMD 110, in response to commands from externalprogrammer 150, delivers electrical stimulation therapy according to aplurality of therapy stimulation programs to a target tissue site of thespinal cord 120 of patient 105 via electrodes (not depicted) on leads130. In some examples, IMD 110 modifies therapy stimulation programs astherapy needs of patient 105 evolve over time. For example, themodification of the therapy stimulation programs may cause theadjustment of at least one parameter of the plurality of informedpulses. When patient 105 receives the same therapy for an extendedperiod, the efficacy of the therapy may be reduced. In some cases,parameters of the plurality of informed pulses may be automaticallyupdated.

Efficacy of electrical stimulation therapy may, in some cases, beindicated by one or more characteristics (e.g. an amplitude of orbetween one or more peaks or an area under the curve of one or morepeaks) of an action potential that is evoked by a stimulation pulsedelivered by IMD 110 (i.e., a characteristic of the ECAP signal). In oneor more cases where stimulation pulses elicit detectible ECAPs,electrical stimulation therapy delivery by leads 130 of IMD 110 maycause neurons within the target tissue to evoke a compound actionpotential that travels up and down the target tissue (e.g., nervefibers), eventually arriving at sensing electrodes of IMD 110.Furthermore, control stimulation may also elicit at least one ECAP, andECAPs responsive to control stimulation may also be a surrogate for theeffectiveness of the therapy. The amount of action potentials (e.g.,number of neurons propagating action potential signals) that are evokedmay be based on the various parameters of electrical stimulation pulsessuch as amplitude, pulse width, frequency, pulse shape (e.g., slew rateat the beginning and/or end of the pulse), etc. The slew rate may definethe rate of change of the voltage and/or current amplitude of the pulseat the beginning and/or end of each pulse or each phase within thepulse. For example, a very high slew rate indicates a steep or even nearvertical edge of the pulse, and a low slew rate indicates a longer rampup (or ramp down) in the amplitude of the pulse over time. In someexamples, these parameters contribute to an intensity of the electricalstimulation. In addition, a characteristic of the ECAP signal (e.g., anamplitude) may change based on the distance between the stimulationelectrodes and the nerves subject to the electrical field produced bythe delivered control stimulation pulses.

In the example of FIG. 1 , IMD 110 may perform a plurality of processingand computing functions. However, external programmer 150 instead mayperform one, several, or all of these functions. In this alternativeexample, IMD 110 may relay sensed signals to external programmer 150 foranalysis, and external programmer 150 may transmit instructions to IMD110 to adjust the one or more parameters defining the electricalstimulation therapy based on analysis of the sensed signals. Forexample, IMD 110 may relay the sensed signal indicative of the sensedECAP signal to external programmer 150.

FIG. 2 is a block diagram illustrating an example configuration ofcomponents of IMD 200, in accordance with one or more techniques of thisdisclosure. IMD 200 may be an example of IMD 110 of FIG. 1 . In theexample shown in FIG. 2 , IMD 200 includes stimulation generationcircuitry 202, switch circuitry 204, sensing circuitry 206,communication circuitry 208, processing circuitry 210, storage device212, sensor(s) 222, and power source 224. As seen in FIG. 2 , sensor(s)222 include acceleration sensor 223.

In the example shown in FIG. 2 , storage device 212 stores therapystimulation programs 214 and test stimulation programs 216 in separatememories within storage device 212 or separate areas within storagedevice 212. Each stored therapy stimulation program of therapystimulation programs 214 defines values for a set of electricalstimulation parameters (e.g., a stimulation parameter set), such as astimulation electrode combination, electrode polarity, current orvoltage amplitude, pulse width, pulse rate, and pulse shape. Each storedtest stimulation programs 216 defines values for a set of electricalstimulation parameters (e.g., a control stimulation parameter set), suchas a stimulation electrode combination, electrode polarity, current orvoltage amplitude, pulse width, pulse rate, and pulse shape. Teststimulation programs 216 may also have additional information such asinstructions regarding when to deliver control pulses based on the pulsewidth and/or frequency of the informed pulses defined in therapystimulation programs 214. In examples in which control pulses areprovided to the patient without the need for informed pulses, a separatetest stimulation program may not be needed. Instead, the teststimulation program for therapy that only includes control pulses maydefine the same control pulses as the corresponding therapy stimulationprogram for those control pulses.

Accordingly, in some examples, stimulation generation circuitry 202generates electrical stimulation signals in accordance with theelectrical stimulation parameters noted above. Other ranges ofstimulation parameter values may also be useful and may depend on thetarget stimulation site within patient 105. While stimulation pulses aredescribed, stimulation signals may be of any form, such ascontinuous-time signals (e.g., sine waves) or the like. Switch circuitry204 may include one or more switch arrays, one or more multiplexers, oneor more switches (e.g., a switch matrix or other collection ofswitches), or other electrical circuitry configured to directstimulation signals from stimulation generation circuitry 202 to one ormore of electrodes 232, 234, or directed sensed signals from one or moreof electrodes 232, 234 to sensing circuitry 206. In other examples,stimulation generation circuitry 202 and/or sensing circuitry 206 mayinclude sensing circuitry to direct signals to and/or from one or moreof electrodes 232, 234, which may or may not also include switchcircuitry 204.

Sensing circuitry 206 monitors signals from any combination ofelectrodes 232, 234. In some examples, sensing circuitry 206 includesone or more amplifiers, filters, and analog-to-digital converters.Sensing circuitry 206 may be used to sense physiological signals, suchas ECAPs. Additionally, or alternatively, sensing circuitry 206 maysense one or more stimulation pulses delivered to patient 105 viaelectrodes 232, 234. In some examples, sensing circuitry 206 detectselectrical signals, such as stimulation signals and/or ECAPs from aparticular combination of electrodes 232, 234. In some cases, theparticular combination of electrodes for sensing ECAPs includesdifferent electrodes than a set of electrodes 232, 234 used to deliverstimulation pulses. Alternatively, in other cases, the particularcombination of electrodes used for sensing ECAPs includes at least oneof the same electrodes as a set of electrodes used to deliverstimulation pulses to patient 105. Sensing circuitry 206 may providesignals to an analog-to-digital converter, for conversion into a digitalsignal for processing, analysis, storage, or output by processingcircuitry 210.

Communication circuitry 208, in the example of FIG. 2 , supportscommunication, including wireless communication, between IMD 200 and anexternal programmer (not shown in FIG. 2 ) or another computing deviceunder the control of processing circuitry 210. Processing circuitry 210of IMD 200 may receive, as updates to programs, values for variousstimulation parameters such as amplitude and electrode combination, fromthe external programmer via communication circuitry 208. Updates to thetherapy stimulation programs 214 and test stimulation programs 216 maybe stored within storage device 212. Communication circuitry 208 in IMD200, as well as communication circuits in other devices and systemsdescribed herein, such as the external programmer, may accomplishcommunication by radiofrequency (RF) communication techniques. Inaddition, communication circuitry 208 may communicate with an externalmedical device programmer (not shown in FIG. 2 ) via proximal inductiveinteraction of IMD 200 with the external programmer. The externalprogrammer may be one example of external programmer 150 of FIG. 1 .Accordingly, communication circuitry 208 may send information to theexternal programmer on a continuous basis, at periodic intervals, orupon request from 1 MB 200 or the external programmer. In some examples,communication circuitry 208 may also support communication between othermedical devices, either implanted in, worn by or in proximity to patient105 depicted in FIG. 1 .

Processing circuitry 210 may include any one or more of amicroprocessor, a controller, a digital signal processor (DSP), anapplication specific integrated circuit (ASIC), a field-programmablegate array (FPGA), discrete logic circuitry, or any other processingcircuitry configured to provide the functions attributed to processingcircuitry 210 herein may be embodied as firmware, hardware, software orany combination thereof. Processing circuitry 210 controls stimulationgeneration circuitry 202 to generate stimulation signals according totherapy stimulation programs 214 and test stimulation programs 216stored in storage device 212 to apply stimulation parameter valuesspecified by one or more of programs, such as amplitude, pulse width,pulse rate, and pulse shape of each of the stimulation signals.

In the example shown in FIG. 2 , the set of electrodes 232 includeselectrodes 232A, 232B, 232C, and 232D, and the set of electrodes 234includes electrodes 234A, 234B, 234C, and 234D. In other examples, asingle lead may include all eight electrodes 232 and 234 along a singleaxial length of the lead. Processing circuitry 210 also controlsstimulation generation circuitry 202 to generate and apply thestimulation signals to selected combinations of electrodes 232, 234. Insome examples, stimulation generation circuitry 202 includes a switchcircuit (instead of, or in addition to, switch circuitry 204) that maycouple stimulation signals to selected conductors within leads 230,which, in turn, deliver the stimulation signals across selectedelectrodes 232, 234. Such a switch circuit may be a switch array, switchmatrix, multiplexer, or any other type of switching circuit configuredto selectively couple stimulation energy to selected electrodes 232, 234and to selectively sense bioelectrical neural signals of a spinal cordof the patient (not shown in FIG. 2 ) with selected electrodes 232, 234.

In other examples, however, stimulation generation circuitry 202 doesnot include a switch circuit and switch circuitry 204 does not interfacebetween stimulation generation circuitry 202 and electrodes 232, 234. Inthese examples, stimulation generation circuitry 202 includes aplurality of pairs of voltage sources, current sources, voltage sinks,or current sinks connected to each of electrodes 232, 234 such that eachpair of electrodes has a unique signal circuit. In other words, in theseexamples, each of electrodes 232, 234 is independently controlled viaits own signal circuit (e.g., via a combination of a regulated voltagesource and sink or regulated current source and sink), as opposed toswitching signals between electrodes 232, 234.

Electrodes 232, 234 on respective leads 230 may be constructed of avariety of different designs. For example, one or both of leads 230 mayinclude one or more electrodes at each longitudinal location along thelength of the lead, such as one electrode at different perimeterlocations around the perimeter of the lead at each of the locations A,B, C, and D. In one example, the electrodes may be electrically coupledto stimulation generation circuitry 202, e.g., via switch circuitry 204and/or switching circuitry of the stimulation generation circuitry 202,via respective wires that are straight or coiled within the housing ofthe lead and run to a connector at the proximal end of the lead. Inanother example, each of the electrodes of the lead may be electrodesdeposited on a thin film. The thin film may include an electricallyconductive trace for each electrode that runs the length of the thinfilm to a proximal end connector. The thin film may then be wrapped(e.g., a helical wrap) around an internal member to form the lead 230.These and other constructions may be used to create a lead with acomplex electrode geometry.

Although sensing circuitry 206 is incorporated into a common housingwith stimulation generation circuitry 202 and processing circuitry 210in FIG. 2 , in other examples, sensing circuitry 206 may be in aseparate housing from IMD 200 and may communicate with processingcircuitry 210 via wired or wireless communication techniques. Processingcircuitry 210 may be configured to receive information indicative of asensed ECAP signal via sensing circuitry 206. In some examples,processing circuitry may receive an analog signal from sensing circuitry206. In other examples, processing circuitry 210 may receive a digitalsignal.

In some examples, sensing circuitry 206 may include specific noisesensing circuitry 207. Noise sensing circuitry 207 may include one ormore bandpass filters, band stop filters, amplifiers, analog and digitalanalysis circuitry, and related circuitry configured to detect noisethat could couple onto leads 230 and be received by sensing circuitry206. In some examples, noise sensing circuitry 207 may be configured todetect specific noise signals, such as 60 Hz signals, 50 Hz signals, orother expected noise signals. Noise sensing circuitry 207 may provide anindication to processing circuitry 210 that noise is present and thatthe ECAP sensing may not be reliable. In some examples, in response toan indication of noise from noise sensing circuitry 207, processingcircuitry 210 may reject a request from a patient programmer to adjuststimulation parameters. For example, processing circuitry 210 may rejectpatient programmer requests to increase stimulation amplitude to avoidpossible patient discomfort when the noise source is removed.

In some examples, one or more of electrodes 232 and 234 are suitable forsensing one or more ECAPs. For instance, electrodes 232 and 234 maysense the voltage amplitude of a portion of the ECAP signals, where thesensed voltage amplitude is a characteristic of the ECAP signal.

In some examples, one or more of electrodes 232 and 234 are suitable forsensing stimulation signals. For instance, electrodes 232 and 234 maysense the voltage amplitude of a portion of the stimulation signals,where the sensed voltage amplitude is a characteristic of thestimulation signals. In some examples, one or more of electrodes 232 and234 may sense a stimulation signal in response to one or more ofelectrodes 232 and 234 delivering a stimulation pulse to target tissueof patient 105. In some examples, the one or more of electrodes 232 and234 which sense the stimulation signal are not the same as the one ormore of electrodes 232 and 234 which deliver the stimulation pulse.

Storage device 212 may be configured to store information within IMD 200during operation. Storage device 212 may include a computer-readablestorage medium or computer-readable storage device. In some examples,storage device 212 includes one or more of a short-term memory or along-term memory. Storage device 212 may include, for example, randomaccess memories (RAM), dynamic random access memories (DRAM), staticrandom access memories (SRAM), magnetic discs, optical discs, flashmemories, or forms of electrically programmable memories (EPROM) orelectrically erasable and programmable memories (EEPROM). In someexamples, storage device 212 is used to store data indicative ofinstructions for execution by processing circuitry 210. As discussedabove, storage device 212 is configured to store therapy stimulationprograms 214, test stimulation programs 216, and target values 218. Insome examples, processing circuitry 210 may implement the closed looppolicy based on an algorithm stored at storage device 212.

In some examples, stimulation generation circuitry 202 may be configuredto deliver electrical stimulation therapy to patient 105. In someexamples, the electrical stimulation therapy may include a plurality ofinformed pulses. Additionally, stimulation generation circuitry 202 maybe configured to deliver a plurality of control pulses, where theplurality of control pulses is interleaved with at least some informedpulses of the plurality of informed pulses. Stimulation generationcircuitry may deliver the plurality of informed pulses and the pluralityof control pulses to target tissue (e.g., spinal cord 120) of patient105 via electrodes 232, 234 of leads 230. By delivering such informedpulses and control pulses, stimulation generation circuitry 202 maycause IMD 200 to sense stimulation signals that are indicative of thedelivered pulses Additionally, or alternatively, stimulation generationcircuitry 202 may deliver control pulses that evoke detectableresponsive ECAPs in the target tissue, the responsive ECAPs propagatingthrough the target tissue before arriving back at electrodes 232, 234.Stimulation signals or ECAPs caused by or elicited by informed pulsesmay not be detectable by IMD 200. In some examples, a differentcombination of electrodes 232, 234 may sense responsive ECAPs and/orresponsive stimulation signals than a combination of electrodes 232, 234that delivers informed pulses and a combination of electrodes 232, 234that delivers control pulses. Sensing circuitry 206 may be configured todetect the responsive ECAPs and/or the responsive stimulation signalsvia electrodes 232, 234 and leads 230. In other examples, stimulationgeneration circuitry 202 may be configured to deliver a plurality ofcontrol pulses, without any informed pulses, when control pulses alsoprovide or contribute to a therapeutic effect for the patient.

Processing circuitry 210 may, in some cases, direct sensing circuitry206 to continuously monitor for ECAPs and stimulation signals. In othercases, processing circuitry 210 may direct sensing circuitry 206 tomonitor for ECAPs and stimulation signals based on signals fromsensor(s) 222. For example, processing circuitry 210 may activatesensing circuitry 206 based on an activity level of patient 105exceeding an activity level threshold (e.g., acceleration sensor 223rises above a threshold). Activating and deactivating sensing circuitry206 may, in some examples, extend a battery life of power source 224.

Processing circuitry 210 may determine whether electrical stimulationtherapy delivered to target tissue of patient 105 via electrodes 232,234 elicits enough detectible ECAPs for processing circuitry 210 todetermine therapy based on one or more characteristics of the respectivedetectible ECAPs. It may be beneficial for processing circuitry 210 todetermine therapy based on characteristics of detectible ECAPs ratherthan characteristics of detectible stimulation signals, if possible.However, if not enough responsive ECAPs are detectible by sensingcircuitry 206, it may be beneficial for processing circuitry 210 todetermine therapy based on one or more characteristics of respectivestimulation signals, which are often still detectible even when some orall of elicited ECAPs are not detectible in response to a stimulationpulse. In addition, sensing circuitry 206 may still detect stimulationsignals when the delivered stimulation pulses were insufficient toelicit a detectable ECAP signal (e.g., when the stimulation pulses areconfigured to be sub-threshold pulses).

In one example, to determine if the electrical stimulation therapyelicits enough detectible ECAPs, processing circuitry 210 is configuredto perform a test to determine whether the plurality of pulses of theelectrical stimulation therapy elicit greater than a threshold ratio ofdetectible ECAPs. For example, to perform the test, processing circuitry210 may identify a set of ECAPs elicited by a sequence of consecutivepulses of the plurality of pulses. Subsequently, processing circuitry210 may calculate a ratio of the set of ECAPs to the sequence ofconsecutive pulses. For example, processing circuitry 210 may firstdetermine a number of ECAPs of the set of ECAPs and a number of pulsesof the sequence of consecutive pulses, and then calculate a ratio of thenumber of ECAPs to the number of pulses.

There may be examples in which a particular one or more stimulationpulses of the sequence of consecutive pulses might not elicit ECAPs thatare detectible by sensing circuitry 206, but another one or morestimulation pulses of the sequence of consecutive pulses do elicit ECAPsthat are detectible by sensing circuitry 206. In such cases, processingcircuitry 210 may be configured to determine therapy based on one ormore characteristics of the detectible ECAPs rather than determinetherapy based on one or more characteristics of detectible stimulationsignals. In some examples, processing circuitry 210 may determinewhether the ratio of detectible ECAPs to stimulation pulses is greaterthan the threshold ratio. In one or more cases where the ratio isgreater than the threshold ratio, processing circuitry 210 may determinetherapy based on characteristics of the detectible ECAPs. In one or morecases where the ratio is not greater than the threshold ratio,processing circuitry 210 may determine therapy based on characteristicsof the detectible stimulation signals.

In some examples, responsive to determining that a plurality of pulseselicit greater than a threshold ratio of detectible ECAPs, processingcircuitry 210 is configured to set, based on one or more characteristicsof an ECAP, one or more parameters which at least partially define theone or more pulses deliverable by stimulation generation circuitry 202after a stimulation pulse which elicits the respective ECAP. In someexamples, responsive to determining that a plurality of pulses do notelicit greater than a threshold ratio of detectible ECAPs, processingcircuitry 210 is configured to set, based on one or more characteristicsof a stimulation signal, one or more parameters which at least partiallydefine the one or more pulses deliverable by stimulation generationcircuitry 202 after a stimulation pulse which elicits the respectivestimulation signal. In some examples, processing circuitry 210 may setone or more parameters which at least partially define the one or morepulses deliverable by stimulation generation circuitry 202 based on acombination of characteristics of one or more detectable ECAPs andcharacteristics of one or more detectible stimulation signals.

Stimulation generation circuitry 202 may be configured to deliver one ormore stimulation pulses, at least one of which may cause sensingcircuitry 206 to sense a stimulation signal in response to the deliveryof the respective pulse. In some examples, to sense a stimulationsignal, sensing circuitry 206 may detect, via any one or combination ofelectrodes 232, 234, one or more electrical signals which are generatedby stimulation generation circuitry 202 and delivered to patient 105 viaany one or combination of electrodes 232, 234. In some examples,stimulation signals may include information which is useful fordetermining one or more parameters of upcoming therapy pulses generatedby stimulation generation circuitry 202. For example, informationincluded by a stimulation signal may include one or more characteristicswhich indicate an efficacy of therapy delivered to patient 105 viaelectrodes 232, 234. In some cases, the one or more characteristics mayreflect a separation between one or more of electrodes 232, 234 andtarget tissue of patient 105 (e.g., spinal cord 120). Such a distancebetween electrodes 232, 234 and spinal cord 120 may be relevant todetermining therapy since a smaller intensity (e.g., amplitude and/orpulse length) of therapy pulses is required to stimulate a nerve ifelectrodes 232, 234 move closer to spinal cord 120 and vice versa.

Determining therapy based on one or more stimulation signals may, insome cases, depend on a posture of patient 105. For example, processingcircuitry 210 may be configured to determine a posture of patient 105based on an acceleration signal generated by acceleration sensor 223. Insome examples, the accelerometer signal includes a vertical component, alateral component, and a frontal component corresponding to a verticalaxis, a lateral axis, and a frontal axis, respectively. In this way, theaccelerometer signal represents a three-dimensional measurement ofacceleration. It may be beneficial for processing circuitry 210 toanalyze one or more of the vertical axes, the lateral axis, and thefrontal axis in order to determine a posture of patient 105.

In some examples, acceleration sensor 223 is configured to generate anaccelerometer signal. Processing circuitry 210 is configured toidentify, based on the accelerometer signal, a posture of a set ofpostures which patient 105 is occupying. The set of postures mayinclude, for example, a standing posture, a sitting posture, a supineposture, a prone posture, a side-lying posture, or any combinationthereof. In some examples, expected parameter values of theaccelerometer signal corresponding to each posture of the set ofpostures are stored in storage device 212. Subsequently, processingcircuitry 210 may select, based on the identified posture, a targetstimulation signal value (e.g., a target range of characteristic values)for a stimulation signal sensed by IMD 200 in response to a delivery ofa corresponding stimulation pulses. For example, if stimulationgeneration circuitry 202 generates a stimulation pulse having astimulation amplitude and delivers the stimulation pulse to targettissue of patient 105 via one or a combination of electrodes 232, 234,processing circuitry 210 may select, based on a posture of patient 105during the delivery of the stimulation pulse, a target range for acharacteristic of the resulting stimulation signal sensed by sensingcircuitry 106. Subsequently, processing circuitry 210 may determinewhether to change one or more parameters of therapy stimulation programs314 and/or test stimulation programs 216 based on whether thecharacteristic value is within the target range of characteristic valuesselected based on the posture of patient 105.

In some examples, processing circuitry 210 is configured to identify,based on the accelerometer signal, a posture of a set of postures whichpatient 105 is occupying while a stimulation pulse is delivered andidentify an amplitude of the stimulation pulse. Subsequently, processingcircuitry 210 may select a target range of characteristic values for acharacteristic of a stimulation signal sensed by sensing circuitry 206in response to the delivery of the stimulation pulse based on both ofthe posture of patient 105 and the amplitude of the stimulation pulse.For example, target values 218 may include a respective transferfunction corresponding to each posture of the set of postures. Eachtransfer function represents a relationship (e.g., a linearrelationship) between the amplitude of a stimulation pulse and thetarget stimulation signal value (e.g., a target range of characteristicvalues) for a stimulation signal sensed by IMD 200 in response to thedelivery of the stimulation pulse. As such, processing circuitry 210may, when evaluating whether to change one or more parameters ofupcoming stimulation pulses, first select a transfer functioncorresponding to a present stimulation pulse and subsequently select atarget range of characteristics based on the amplitude of the presentstimulation pulse, but this is not required. Processing circuitry 210may first analyze the amplitude of the stimulation pulse andsubsequently determine the posture of patient 105, in some cases.

Power source 224 is configured to deliver operating power to thecomponents of IMD 200. Power source 224 may include a battery and apower generation circuit to produce the operating power. In someexamples, the battery is rechargeable to allow extended operation. Insome examples, recharging is accomplished through proximal inductiveinteraction between an external charger and an inductive charging coilwithin IMD 200. Power source 224 may include any one or more of aplurality of different battery types, such as nickel cadmium batteriesand lithium ion batteries.

FIG. 3 is a block diagram illustrating an example configuration ofcomponents of external programmer 300, in accordance with one or moretechniques of this disclosure. External programmer 300 may be an exampleof external programmer 150 of FIG. 1 . Although external programmer 300may generally be described as a hand-held device, external programmer300 may be a larger portable device or a more stationary device. Inaddition, in other examples, external programmer 300 may be included aspart of an external charging device or include the functionality of anexternal charging device. As illustrated in FIG. 3 , external programmer300 may include processing circuitry 352, storage device 354, userinterface 356, telemetry circuitry 358, and power source 360. Storagedevice 354 may store instructions that, when executed by processingcircuitry 352, cause processing circuitry 352 and external programmer300 to provide the functionality ascribed to external programmer 300throughout this disclosure. Each of these components, circuitry, ormodules, may include electrical circuitry that is configured to performsome, or all of the functionality described herein. For example,processing circuitry 352 may include processing circuitry configured toperform the processes discussed with respect to processing circuitry352.

In general, external programmer 300 includes any arrangement ofhardware, alone or in combination with software and/or firmware,configured to perform the techniques attributed to external programmer300, and processing circuitry 352, user interface 356, and telemetrycircuitry 358 of external programmer 300. In various examples, externalprogrammer 300 may include one or more processors, such as one or moremicroprocessors, DSPs, ASICs, FPGAs, or any other equivalent integratedor discrete logic circuitry, as well as any combinations of suchcomponents. External programmer 300 also, in various examples, mayinclude a storage device 354, such as RAM, ROM, PROM, EPROM, EEPROM,flash memory, a hard disk, a CD-ROM, including executable instructionsfor causing the one or more processors to perform the actions attributedto them. Moreover, although processing circuitry 352 and telemetrycircuitry 358 are described as separate modules, in some examples,processing circuitry 352 and telemetry circuitry 358 are functionallyintegrated. In some examples, processing circuitry 352 and telemetrycircuitry 358 correspond to individual hardware units, such as ASICs,DSPs, FPGAs, or other hardware units.

Storage device 354 (e.g., a storage device) may store instructions that,when executed by processing circuitry 352, cause processing circuitry352 and external programmer 300 to provide the functionality ascribed toexternal programmer 300 throughout this disclosure. For example, storagedevice 354 may include instructions that cause processing circuitry 352to obtain a parameter set from memory, select a spatial electrodemovement pattern, or receive a user input and send a correspondingcommand to IMD 200, or instructions for any other functionality. Inaddition, storage device 354 may include a plurality of programs, whereeach program includes a parameter set that defines stimulation pulses,such as control pulses and/or informed pulses. Storage device 354 mayalso store data received from a medical device (e.g., IMD 110). Forexample, storage device 354 may store ECAP related data recorded at asensing module of the medical device, and storage device 354 may alsostore data from one or more sensors of the medical device.

User interface 356 may include a button or keypad, lights, a speaker forvoice commands, a display, such as a liquid crystal (LCD),light-emitting diode (LED), or organic light-emitting diode (OLED). Insome examples the display includes a touch screen. User interface 356may be configured to display any information related to the delivery ofelectrical stimulation, identified patient behaviors, sensed patientparameter values, patient behavior criteria, or any other suchinformation. User interface 356 may also receive user input via userinterface 356. The input may be, for example, in the form of pressing abutton on a keypad or selecting an icon from a touch screen. The inputmay request starting or stopping electrical stimulation, the input mayrequest a new spatial electrode movement pattern or a change to anexisting spatial electrode movement pattern, of the input may requestsome other change to the delivery of electrical stimulation. Forexample, the input may request an increase or decrease to stimulationintensity (e.g., amplitude, pulse width, or frequency). Programmer 300can then transmit these requests to IMD 200. Programmer 300 may receive,and transmit, the input requesting changes to one or more parametervalues during closed-loop stimulation in some examples.

Telemetry circuitry 358 may support wireless communication between themedical device and external programmer 300 under the control ofprocessing circuitry 352. Telemetry circuitry 358 may also be configuredto communicate with another computing device via wireless communicationtechniques, or direct communication through a wired connection. In someexamples, telemetry circuitry 358 provides wireless communication via anRF or proximal inductive medium. In some examples, telemetry circuitry358 includes an antenna, which may take on a variety of forms, such asan internal or external antenna.

Examples of local wireless communication techniques that may be employedto facilitate communication between external programmer 300 and IMD 110include RF communication according to the 802.11 or Bluetooth®specification sets or other standard or proprietary telemetry protocols.In this manner, other external devices may be capable of communicatingwith external programmer 300 without needing to establish a securewireless connection. As described herein, telemetry circuitry 358 may beconfigured to transmit a spatial electrode movement pattern or otherstimulation parameter values to IMD 110 for delivery of electricalstimulation therapy.

In some examples, selection of stimulation parameters or therapystimulation programs are transmitted to the medical device for deliveryto a patient (e.g., patient 105 of FIG. 1 ). In other examples, thetherapy may include medication, activities, or other instructions thatpatient 105 must perform themselves or a caregiver perform for patient105. In some examples, external programmer 300 provides visual, audible,and/or tactile notifications that indicate there are new instructions.External programmer 300 requires receiving user input acknowledging thatthe instructions have been completed in some examples.

According to the techniques of the disclosure, user interface 356 ofexternal programmer 300 receives an indication from a clinicianinstructing a processor of the medical device to update one or moretherapy stimulation programs or to update one or more test stimulationprograms. Updating therapy stimulation programs and test stimulationprograms may include changing one or more parameters of the stimulationpulses delivered by the medical device according to the programs, suchas amplitude, pulse width, frequency, and pulse shape of the informedpulses and/or control pulses. User interface 356 may also receiveinstructions from the clinician commanding any electrical stimulation,including control pulses and/or informed pulses to commence or to cease.

Power source 360 is configured to deliver operating power to thecomponents of external programmer 300. Power source 360 may include abattery and a power generation circuit to produce the operating power.In some examples, the battery is rechargeable to allow extendedoperation. Recharging may be accomplished by electrically coupling powersource 360 to a cradle or plug that is connected to an alternatingcurrent (AC) outlet. In addition, recharging may be accomplished throughproximal inductive interaction between an external charger and aninductive charging coil within external programmer 300. In otherexamples, traditional batteries (e.g., nickel cadmium or lithium ionbatteries) may be used. In addition, external programmer 300 may bedirectly coupled to an alternating current outlet to operate.

FIG. 4 is a graph 402 of example evoked compound action potentials(ECAPs) sensed for respective stimulation pulses, in accordance with oneor more techniques of this disclosure. As shown in FIG. 4 , graph 402shows example ECAP signal 404 (dotted line) and ECAP signal 406 (solidline). In some examples, each of ECAP signals 404 and 406 are sensedfrom stimulation pulses (e.g., a control pulse) that were delivered froma guarded cathode, where the stimulation pulses are bi-phasic pulsesincluding an interphase interval between each positive and negativephase of the pulse. In some such examples, the guarded cathode includesstimulation electrodes located at the end of an 8-electrode lead (e.g.,leads 130 of FIG. 1 ) while two sensing electrodes are provided at theother end of the 8-electrode lead. ECAP signal 404 illustrates thevoltage amplitude sensed as a result from a sub-detection thresholdstimulation pulse, or a stimulation pulse which results in no detectableECAP. It is noted that monophasic, tri-phasic, or pulses with anotherquantity of phases may be in other examples.

Peaks 408 of ECAP signal 404 are detected and represent stimulationsignals of the delivered stimulation pulse. However, no propagatingsignal is detected after the stimulation signal in ECAP signal 404because the stimulation pulse had an intensity (e.g., an amplitudeand/or pulse width) that was “sub-threshold” or below a detectionthreshold (e.g., a sub-detection threshold) and/or below a propagationthreshold (e.g., a sub-propagation threshold). In other examples,sensing circuitry, such as sensing circuitry 206 described above inrelation to FIG. 2 , may measure other signal features, such as featuresbased on a derivative of the sensed signal, slope, linearity, and so on.The processing circuitry may react to the peaks 408 of ECAP signal 404,or any other measurable or calculated signal feature.

In contrast to ECAP signal 404, ECAP signal 406 represents the voltageamplitude detected from a supra-detection stimulation thresholdstimulation pulse. Peaks 408 of ECAP signal 406 are detected andrepresent stimulation signals of the delivered stimulation pulse. Afterpeaks 408, ECAP signal 406 also includes peaks P1, N1, and P2, which arethree typical peaks representative of propagating action potentials froman ECAP. The example duration of the stimulation signal and peaks P1,N1, and P2 is approximately 1 millisecond (ms).

When detecting the ECAP of ECAP signal 406, different characteristicsmay be identified. For example, the characteristic of the ECAP may bethe amplitude between N1 and P2. This N1-P2 amplitude may be easilydetectable even if the stimulation signal impinges on P1, a relativelylarge signal, and the N1-P2 amplitude may be minimally affected byelectronic drift in the signal. In other examples, the characteristic ofthe ECAP used to control subsequent stimulation pulses (e.g., controlpulses and/or informed pulses) may be an amplitude of P1, N1, or P2 withrespect to neutral or zero voltage. In some examples, the characteristicof the ECAP used to control subsequent stimulation pulses is a sum oftwo or more of peaks P1, N1, or P2. In other examples, thecharacteristic of ECAP signal 406 may be the area under one or more ofpeaks P1, N1, and/or P2. In other examples, the characteristic of theECAP may be a ratio of one of peaks P1, N1, or P2 to another one of thepeaks. In some examples, the characteristic of the ECAP is a slopebetween two points in the ECAP signal, such as the slope between N1 andP2. In other examples, the characteristic of the ECAP may be the timebetween two points of the ECAP, such as the time between N1 and P2.

The time between when the stimulation pulse is delivered and a point inthe ECAP signal may be referred to as a latency of the ECAP and mayindicate the types of fibers being captured by the stimulation pulse(e.g., a control pulse). ECAP signals with lower latency (i.e., smallerlatency values) indicate a higher percentage of nerve fibers that havefaster propagation of signals, whereas ECAP signals with higher latency(i.e., larger latency values) indicate a higher percentage of nervefibers that have slower propagation of signals. Latency may also referto the time between an electrical feature is detected at one electrodeand then detected again at a different electrode. This time, or latency,is inversely proportional to the conduction velocity of the nervefibers. Other characteristics of the ECAP signal may be used in otherexamples.

The amplitude of the ECAP signal increases with increased amplitude ofthe stimulation pulse, as long as the pulse amplitude is greater thanthreshold such that nerves depolarize and propagate the signal. Thetarget ECAP characteristic (e.g., the target ECAP amplitude) may bedetermined from the ECAP signal detected from a stimulation pulse (or acontrol pulse) when informed pulses are determined to deliver effectivetherapy to patient 105. The ECAP signal thus is representative of thedistance between the stimulation electrodes and the nerves appropriatefor the stimulation parameter values of the informed pulses delivered atthat time. Therefore, IMD 110 may attempt to use detected changes to themeasured ECAP characteristic value to change therapy pulse parametervalues and maintain the target ECAP characteristic value during therapypulse delivery.

FIG. 5 is a timing diagram 500 illustrating one example of electricalstimulation pulses, respective stimulation signals, and respectivesensed ECAPs, in accordance with one or more techniques of thisdisclosure. For convenience, FIG. 5 is described with reference to IMD200 of FIG. 2 . As illustrated, timing diagram 500 includes firstchannel 510, a plurality of control pulses 512A-512N (collectively“control pulses 512”), second channel 520, a plurality of informedpulses 524A-524N (collectively “informed pulses 524”) including passiverecharge phases 526A-526N (collectively “passive recharge phases 526”),third channel 530, a plurality of respective ECAPs 536A-536N(collectively “ECAPs 536”), and a plurality of stimulation signals538A-538N (collectively “stimulation signals 538”).

In some examples, external noise from a fourth channel 540 may interferewith the operation of an IMD, such as IMD 200 of FIG. 2 and IMD 110 ofFIG. 1 . Noise on channel 540 may couple to any of leads 230, electrodes232 and 234, and in some examples couple to the IMD. Sensing circuitry206 may sense noise from channel 540. Some of the noise may not becanceled or excluded by the filter circuitry of sensing circuitry 206,and processing circuitry 210 may interpret noise from channel 540 as areceived ECAP signal. Sources of noise may include nearby electricmotors, microwave ovens, machinery, computing devices, rechargingcircuits, generators, and so on. As one example, patient 105 may beseated in a powered massage chair that may include motors and othercircuitry. Noise generated by the massage chair circuitry may coupleinto sensing circuitry 206. Also, pressure rollers in the massage chairmay press against leads 230 and change the position of the lead withrespect to the target tissue of patient 105. As shown in FIG. 5 , thenoise signal on channel 540 may vary in amplitude, frequency, and othercharacteristics, and may start and stop at different times duringoperation of IMD 200.

First channel 510 is a time/voltage (and/or current) graph indicatingthe voltage (or current) of at least one electrode of electrodes 232,234. In one example, the stimulation electrodes of first channel 510 maybe located on the opposite side of the lead as the sensing electrodes ofthird channel 530. Control pulses 512 may be electrical pulses deliveredto the spinal cord of the patient by at least one of electrodes 232,234, and control pulses 512 may be balanced biphasic square pulses withan interphase interval. In other words, each of control pulses 512 areshown with a negative phase and a positive phase separated by aninterphase interval. For example, a control pulse 512 may have anegative voltage for the same amount of time that it has a positivevoltage. It is noted that the negative voltage phase may be before orafter the positive voltage phase. Control pulses 512 may be deliveredaccording to test stimulation programs 216 stored in storage device 212of IMD 200, and test stimulation programs 216 may be updated accordingto user input via an external programmer and/or may be updated accordingto a signal from sensor(s) 222. In one example, control pulses 512 mayhave a pulse width of less than approximately 300 microseconds (e.g.,the total time of the positive phase, the negative phase, and theinterphase interval is less than 300 microseconds). In another example,control pulses 512 may have a pulse width of approximately 100 μs foreach phase of the bi-phasic pulse. As illustrated in FIG. 5 , controlpulses 512 may be delivered via first channel 510. Delivery of controlpulses 512 may be delivered by leads 230 in a guarded cathode electrodecombination. For example, if leads 230 are linear 8-electrode leads, aguarded cathode combination is a central cathodic electrode with anodicelectrodes immediately adjacent to the cathodic electrode.

Second channel 520 is a time/voltage (and/or current) graph indicatingthe voltage (or current) of at least one electrode of electrodes 232,234 for the informed pulses. In one example, the electrodes of secondchannel 520 may partially or fully share common electrodes with theelectrodes of first channel 510 and third channel 530. Informed pulses524 may also be delivered by the same leads 230 that are configured todeliver control pulses 512. Informed pulses 524 may be interleaved withcontrol pulses 512, such that the two types of pulses are not deliveredduring overlapping periods of time. However, informed pulses 524 may ormay not be delivered by exactly the same electrodes that deliver controlpulses 512. Informed pulses 524 may be monophasic pulses with pulsewidths of greater than approximately 300 μs and less than approximately1000 μs. In fact, informed pulses 524 may be configured to have longerpulse widths than control pulses 512. As illustrated in FIG. 5 ,informed pulses 524 may be delivered on second channel 520.

Informed pulses 524 may be configured for passive recharge. For example,each informed pulse 524 may be followed by a passive recharge phase 526to equalize charge on the stimulation electrodes. Unlike a pulseconfigured for active recharge, where remaining charge on the tissuefollowing a stimulation pulse is instantly removed from the tissue by anopposite applied charge, passive recharge allows tissue to naturallydischarge to some reference voltage (e.g., ground or a rail voltage)following the termination of the therapy pulse. In some examples, theelectrodes of the medical device may be grounded at the medical devicebody. In this case, following the termination of informed pulse 524, thecharge on the tissue surrounding the electrodes may dissipate to themedical device, creating a rapid decay of the remaining charge at thetissue following the termination of the pulse. This rapid decay isillustrated in passive recharge phases 526. Passive recharge phase 526may have a duration in addition to the pulse width of the precedinginformed pulse 524. In other examples (not pictured in FIG. 5 ),informed pulses 524 may be bi-phasic pulses having a positive andnegative phase (and, in some examples, an interphase interval betweeneach phase) which may be referred to as pulses including activerecharge. An informed pulse that is a bi-phasic pulse may or may nothave a following passive recharge phase.

Third channel 530 is a time/voltage (and/or current) graph indicatingthe voltage (or current) of at least one electrode of electrodes 232,234. In one example, the electrodes of third channel 530 may be locatedon the opposite side of the lead as the electrodes of first channel 510.ECAPs 536 may be sensed at electrodes 232, 234 from the spinal cord ofthe patient in response to control pulses 512. ECAPs 536 are electricalsignals which may propagate along a nerve away from the origination ofcontrol pulses 512. In one example, ECAPs 536 are sensed by differentelectrodes than the electrodes used to deliver control pulses 512. Asillustrated in FIG. 5 , ECAPs 536 may be recorded on third channel 530.

Stimulation signals 538A, 538B, and 538N may be sensed by leads 230 andmay be sensed during the same period of time as the delivery of controlpulses 512 and informed pulses 524. Since the stimulation signals mayhave a greater amplitude and intensity than ECAPs 536, any ECAPsarriving at IMD 200 during the occurrence of stimulation signals 538 maynot be adequately sensed by sensing circuitry 206 of IMD 200. However,ECAPs 536 may be sufficiently sensed by sensing circuitry 206 becauseeach ECAP 536 falls after the completion of each a control pulse 512 andbefore the delivery of the next informed pulse 524. As illustrated inFIG. 5 , stimulation signals 538 and ECAPs 536 may be recorded onchannel 530. In some examples, noise from channel 540 may be interpretedas ECAPs 536. In other words, noise from channel 540 may cause the IMDto interpret that a value of a characteristic of one or more sensedECAPs 536 is outside of a predetermined range. As described above inrelation to FIGS. 1 and 2 , a closed loop algorithm executed byprocessing circuitry on either IMD 110, IMD 200 or external programmer150 may adjust the one or more parameters defining the electricalstimulation therapy based on analysis of the sensed signals. Forexample, the processing circuitry may compare a characteristic value ofthe stimulation signal to the respective target range of characteristicvalues, and in response to the comparison, the closed loop algorithmexecuted by the processing circuitry may adjust one or more parametersthat define the electrical stimulation pulses delivered to patient 105.In some examples, based on the closed loop algorithm, processingcircuitry 210 may cause stimulation generation circuitry 202 to adjust afirst set of parameter values for the plurality of pulses to a secondset of parameter values. As one example, stimulation generationcircuitry 202 may reduce an amplitude of current for a control pulse orfor an informed pulse, or both, from a first current amplitude to asecond current amplitude. In other examples, stimulation generationcircuitry 202 may also adjust one or more of pulse width, voltageamplitude or other parameters in the set of parameters from a firstvalue to a second value.

As described above in relation to FIG. 2 , processing circuitry 210 mayreceive commands from a patient programmer, e.g. external programmer150, when the patient wishes to terminate or change electricalstimulation therapy. In some examples, the medical device may beadapting to changes in the patient's physiological signals, such as whenthe patient changes posture, activity level. The patient may request anincrease in stimulation (e.g., increase the value of the amplitudeparameter) while IMD 200 is decreasing stimulation due to elevatedcharacteristic values of the sensed ECAP signals (which may be due tonoise). In other examples, noise from channel 540 may be sensed as ECAPs536 exceeding an upper limit of a predetermined range and the closedloop algorithm of IMD 200 may respond by decreasing a parameter value toreduce the sensed ECAP. To avoid the risk of patient discomfort when thenoise is removed (or no longer present), or when the physiologicalsignals change again, in some examples, processing circuitry 210 mayprevent stimulation generation circuitry 202 from responding to thecommands from the patient programmer when processing circuitry 210determines that stimulation therapy parameters, e.g. informed pulseamplitude, is outside of a predetermined pulse amplitude range of adefault pulse amplitude. For example, processing circuitry 210 mayreject a user command to increase amplitude of stimulation when theclosed loop algorithm is reducing amplitude in response to elevatedcharacteristics of the ECAP signal.

In some examples, when noise from channel 540 is sensed as ECAPs 536exceeding an upper limit of a predetermined range and the closed loopalgorithm of IMD 200 responds by decreasing a parameter value to reducethe sensed ECAP, processing circuitry may determine that the sensed ECAPis distorted by noise. For example, a control pulse or an informed pulsemay have a minimum parameter value, such as a pulse amplitude of zero orpulse width of zero. When the closed loop algorithm adjusts theparameter to the minimum value, and the ECAP sensed by sensing circuitry206 is still above the upper limit, processing circuitry 210 maydetermine that noise coupled from channel 540 may be causing the highvalue of the sensed ECAP. In some examples, processing circuitry 210 maydisable the closed loop algorithm when processing circuitry determinesthat the sensed ECAPs 536 may be influenced by noise coupled fromchannel 540. Processing circuitry 210 may execute a control policy toramp the stimulation pulse parameter to a specified value, such as adefault value, until processing circuitry 210 determines that the noisehas diminished or been removed. In this manner, IMD 200 may avoid pulsestimulation parameter levels that may cause the patient to receiveinappropriate stimulation (over or under stimulation) resulting inpatient discomfort.

FIG. 6 is a timing diagram illustrating a closed loop response to asensed ECAP that is outside of a predetermined range, in accordance withone or more techniques of this disclosure. As described above, in thisdisclosure the closed loop algorithm may be referred to as ECAPresponsive stimulation or ERS. The example of FIGS. 6-16 will bedescribed in terms of FIG. 2 , unless otherwise noted. Programmingcommands for ERS may be stored at storage device 212, e.g. at teststimulation programs 216.

Storage device 212 may store a predetermined range for one or morevalues of a characteristic of the sensed ECAP. In the example of FIG. 6, the predetermined range includes an ECAP high threshold (ETH 602) andan ECAP low threshold (ETL 604) for a sensed magnitude (voltage orcurrent). Processing circuitry 210 may determine a value of acharacteristic of the sensed ECAP (600) that is outside of apredetermined range, when the sensed ECAP signal exceeds the ECAP highthreshold 602. In response, ERS may be configured to adjust a first setof parameter values for stimulation pulses delivered during the time thesensed ECAP exceeds ETH 602 to a second set of parameter values (610).In the example of FIG. 6 , processing circuitry 210 may causestimulation generation circuitry 202 to reduce the control pulse currentamplitude Ic 612 from Ict 606 to a lower amplitude. Similarly,stimulation generation circuitry 202 may reduce informed pulse currentamplitude Ii 614 from Iit 608 to a lower amplitude. In this disclosure,Ict 606 is the default control pulse current amplitude, and Iit 608 isthe default informed pulse current amplitude. As described above inrelation to FIGS. 1 and 2 , current pulse amplitude is just one exampleof a parameter value that defines the stimulation pulse delivered by IMD200. In other examples, stimulation generation circuitry 202 may adjustpulse width, voltage amplitude, pulse shape, frequency, and so on, basedon commands from processing circuitry 210.

As the high sensed ECAP signal 600 falls below ETH 602 and back withinthe predetermined range, ERS, executed by processing circuitry 210, mayincrease control pulse current amplitude Ic 612 and informed pulsecurrent amplitude Ii 614 back to the default values of Ict 606 and Iit608 (618).

FIG. 7 is a timing diagram illustrating suspending a closed loopalgorithm, in accordance with one or more techniques of this disclosure.Similar to the example of FIG. 6 , processing circuitry 210 maydetermine that the high sensed ECAP signal 700 exceeds ETH 702 and beginto decrease control pulse current amplitude Ic 712 from Ict 706 to alower amplitude. Similarly, stimulation generation circuitry 202 mayreduce informed pulse current amplitude Ii 714 from Iit 708 to a loweramplitude. However, in the example of FIG. 7 , high sensed ECAP 700persists, which may result in processing circuitry 210 adjusting controlpulse current amplitude Ic 712 and/or informed pulse current amplitudeIi 714 to a minimum value, such as an amplitude of approximately zeroamps (710). In response to adjusting the stimulation amplitude to theminimum value, processing circuitry 210 may start a noise detectiontimer, Tdetect 720. In the example of FIG. 7 , in response todetermining that Tdetect 720 has expired and the sensed ECAP 700 stillexceed ETH 702, processing circuitry 210 may disable the closed-loopalgorithm (722).

As described above in relation to FIG. 5 , processing circuitry 210 mayalso disable some requests from patient programmer 150 while a controlpolicy is adjusting stimulation parameters. One of several possibletechniques to determine whether a control policy is adjustingstimulation parameters is to determine whether control pulse currentamplitude Ic 712 and/or informed pulse current amplitude Ii 714 isoutside of a predetermined range from the default values Ict 706 and Iit708. Other example techniques may include checking a flag stored inmemory that processing circuitry 210 may set when adjusting stimulationparameters. For example, if the flag is cleared, processing circuitry210 may allow requests from patient programmer 150 to adjust stimulationparameters. If the flag is set, processing circuitry 210 may allowrequests to decrease stimulation, but reject requests to increasestimulation.

In the example of FIG. 7 , the predetermined range from the defaultvalues may be a range (±δIct) about the controlled pulse default valuei.e., 2δIct 724. Similarly, the predetermined range may be a range(±δIit) about the informed pulse default value, i.e., 2δIit 726. Inother words, processing circuitry 210 may determine whether the set ofparameter values for the electrical stimulation therapy control pulsecurrent amplitude Ic 712 and/or informed pulse current amplitude Ii 714is approximately equal to the default set of parameter values Ict 706and Iit 708. Because the sensed ECAP 700 is high and ERS has caused Ic712 and Ii 714 to decrease to minimum levels, processing circuitry woulddetermine that Ic 712 and Ii 714 are outside the predetermined range,2δIct 724 and 2δIit 726 respectively, from the default values Ict 706and Iit 708, and therefore may disable patient programmer input fromchanging the stimulation pulse parameters.

FIG. 8 is a timing diagram illustrating a medical device providingelectrical stimulation while suspending a closed loop algorithm, inaccordance with one or more techniques of this disclosure. In theexample of noise, e.g. from channel 540 of FIG. 5 , causing sensed ECAP800 to exceed ETH 802 for an extended period, the closed loop algorithmmay decrease the stimulation pulses, e.g. as shown in FIG. 7 , which mayresult in under stimulation for the patient. The patient, e.g. patient105 of FIG. 1 , may experience discomfort such as a return of painsymptoms, Parkinson's symptoms etc. as a result of the under stimulationcaused by the presence of noise.

In the example of FIG. 8 , in response to suspending ERS (810),processing circuitry 210 may cause stimulation generation circuitry 202to increase the pulse parameter values of Ic 812 and Ii 814 back to thedefault values Ict 806 and Iit 808. In other words, in response todisabling the closed loop algorithm (810), the processing circuitry mayadjust the informed pulse parameter values and the control pulseparameter values from the minimum of parameter values to the default setof parameter values (813). In this manner IMD 200 may continue todeliver therapy in the presence of noise. ERS may remain suspended andany sensed ECAP may be only monitored, but not affect the therapydelivery. Although the control pulse amplitude and informed pulseamplitude are shown as a continuous ramped back to their respectivedefault levels, IMD 200 may use a step-wise ramp or immediate singlejump back to their default levels in other examples.

In other examples, (not shown in FIG. 8 ), IMD 200 may ramp theparameter values, e.g. the stimulation levels of Ic 812 and Ii 814 to avalue different from the default values Ict 806 and Iit 808. Forexample, IMD 200 may ramp the parameter values to a percentage of thedefault values Ict 806 and Iit 808, e.g. 70%, 75% or some otherpercentage. Returning to a sub-default level may provide an advantage byproviding some stimulation for therapeutic purposes while avoidingpossible overstimulating the patient if the patient is in an awkwardposture where returning to the default level would overstimulate thetarget tissue, e.g. the spinal cord. In other words, returning to asub-default may balance sufficient stimulation while lowering the riskof ‘overstimulation’ caused by patient posture or other reasons.

FIG. 9 is a timing diagram illustrating an example of recovering asuspended closed-loop algorithm, in accordance with one or moretechniques of this disclosure. As described above in relation to FIG. 8, processing circuitry 210 may cause Ic 912 and Ii 914 to increase backto the default values Ict 906 and Iit 908 to avoid under stimulationwhile noise may impact ECAP measurement. In the example of FIG. 9 ,while ERS is suspended 922, processing circuitry 210 may monitor ECAPsignals from sensing circuitry 206 but make no adjustments tostimulation pulse parameters.

When the sensed ECAP falls back into the predetermined range, betweenETH 902 and ETL 904, processing circuitry 210 may start a low-noisetimer, T_(low-noise) 920. In response to determining that low-noisetimer 920 has expired, processing circuitry 210 may resume theclosed-loop algorithm (924). In other words, when processing circuitry210 detects that the noise has abated, e.g. ECAP 900 is less than ETH902 for at least the duration of T_(low-noise) 920, processing circuitry210 may enable ERS. With ERS enabled, processing circuitry may causestimulation generation circuitry 202 to adjust stimulation pulseparameters in response to changes in the sensed ECAP. Also, with Ic 912and Ii 914 approximately equal to the default values Ict 906 and Iit908, processing circuitry may respond to commands from patientprogrammer 150.

FIG. 10 is a flow diagram illustrating an example operation forsuspending and recovering a suspended closed-loop algorithm, inaccordance with one or more techniques of this disclosure. The flowdiagram of FIG. 10 is an example of the techniques described by FIGS.7-9 . Although processing circuitry 210 is described as performing thetechnique of FIG. 10 , other circuitry of IMD and/or other devices mayperform some or all of the technique in other examples.

Processing circuitry 210 may receive an indication from sensingcircuitry 206 whether the value of a characteristic of sensed one ormore sensed ECAPs 536 from FIG. 5 may be outside of a target range(1000). When sensed ECAP values are within the target range (NO branchof 1000) processing circuitry 210 may hold the value of the set ofparameter values, e.g. Ic and Ii, for the plurality of pulses (1002).Processing circuitry 210 may continue to monitor ECAP values. In thisdisclosure, “sensing an ECAP” and “measuring an ECAP” is equivalent tosensing one or more ECAP values, and “a value of a characteristic of theECAP,” such as, sensing a voltage amplitude as described above inrelation to FIG. 4 , by sensing circuitry 206.

If processing circuitry 210 determines that ECAP values are outside thetarget range (YES branch of 1000), processing circuitry 210 may checkwhether the ECAP values are higher than the ECAP high threshold (YESbranch of 1004). Processing circuitry 210 may decrement Ic and Ii (1010)until the one or more values of the set of values reaches a minimumvalue. In the example of FIG. 10 , processing circuitry 210 maydetermine that the amplitude of current for the control pulses (Ic) hasnot reached the minimum value (NO branch of 1012) and continue tomonitor ECAP values.

If the ECAP values are outside of the range, but not higher than theECAP high threshold (NO branch of 1004), processing circuitry 210 mayincrement Ic and Ii (1008) and continue to monitor ECAP values. In otherwords, if the ECAP values are outside of the range, but less than theECAP high threshold, the ECAP values must be less than the low ECAPthreshold.

When processing circuitry 210 determines that Ic=0, i.e. the minimumvalue of control pulse amplitude (YES branch of 1012), processingcircuitry may start a noise detection timer, Tdetect. If the ECAP valuesstay above ETH during Tdetect and Tdetect expires (YES branch of 1014),processing circuitry 210 may suspend ERS (1016) and begin to incrementboth Ic and Ii (1018) until Ic and Ii reach the default values, e.g. Ict606 and Iit 608 from FIG. 6 (NO branch of 1020). When Ic and Ii reachthe default values (YES branch of 1020), processing circuitry may holdIc and Ii at the default values (1022) and monitor ECAP values. In otherexamples, (not shown in FIG. 10 ), processing circuitry 210 may set Icand Ii directly to the default values during this period without theincremental increases.

As described above in relation to FIG. 9 , when the ECAP values are lessthan ETH (YES branch of 1024) processing circuitry may start a low noisetimer, e.g. Tlow-noise 920. When the low noise timer has expired (YESbranch of 1026), processing circuitry 210 may restart the closed loopalgorithm, e.g. ERS, (1028) and continue to monitor ECAP values.

As described above in relation to FIG. 8 , in other examples, processingcircuitry may increment both Ic and Ii (1018) until Ic and Ii reach asub-default value rather than the default value (not shown in FIG. 10 ).In other words, processing circuitry may temporarily disable closed-loopoperation in the presence of noise and return to some level oftherapeutic energy. In some examples, the sub-default value may be apercentage of the default value (not shown in FIG. 10 ). In otherexamples, processing circuitry may return the parameter values to anaverage, median or some other calculated stimulation level collectedduring some interval prior to the detection of noise. For example,processing circuitry may use a moving window of delivered stimulationlevels and calculate a parameter value over the duration of the movingwindow. If noise is detected, then the processing circuitry may returnthe parameter value to the calculated level determined prior to theinitial noise detect.

FIG. 11 is a timing diagram illustrating an example of a medical deviceproviding electrical stimulation while suspending a closed loopalgorithm, in accordance with one or more techniques of this disclosure.The example of FIG. 11 provides an alternative option to the techniquesdescribed by FIGS. 7-10 . In contrast to FIGS. 7 and 10 , onceprocessing circuitry 210 determines that ERS should be suspended (1112),e.g. because ECAPs value 1100 is above ETL 1104 and ETH 1102 for anextend time, processing circuitry 210 may increment only the informedpulse current amplitude Ii 1114 to the default value Iit 1108. Thecontrol pulse amplitude Ic, may remain at the minimum value, rather thanreturning to the default value of Ict 1106 (1116). Since the controlpulse amplitude Ic is what elicits the sensed ECAP signal, a controlpulse amplitude Ic at zero should not result in any detectable ECAPsignal. In contrast, informed pulse current amplitude Ii can return todefault value Iit 1108 in order to reestablish stimulation therapy.

FIG. 12 is a timing diagram illustrating an example of a medical devicesensing noise abatement while suspending a closed loop algorithm, inaccordance with one or more techniques of this disclosure. As describedabove in relation to FIG. 11 , processing circuitry 210 may increaseinformed pulse current amplitude Ii 1214 to the default value Iit 1208while control pulse amplitude Ic 1212, may remain at the minimum valueduring noise detection and ERS is suspended 1218.

When the noise no longer affects the ECAP value, the ECAP value may dropbelow ETL 1204 because while the control pulse amplitude is zero (Ic=0),IMD 200 should not generate a detectable ECAP value (e.g., there shouldbe no ECAP signal without a stimulation pulse to elicit such an ECAPsignal). Processing circuitry 210 may receive an indication from sensingcircuitry 206 that the ECAP value has settled below ETL 1204 (1200) andmay start a low-noise timer T_(low-noise) 1216. In the example of FIG.12 , processing circuitry may determine noise has abated when Ic=0, theECAP value is below both ETH 1202 and ETL 1204 and T_(low-noise) 1216has expired (1222). Put another way, processing circuitry 210 maydetermine that the noise has abated because the ECAP value has droppedto expected levels with a lack of any control pulse being delivered thatis capable of eliciting a detectable ECAP signal.

FIG. 13 is a timing diagram illustrating another example of recovering asuspended closed-loop algorithm, in accordance with one or moretechniques of this disclosure. As described above in relation to FIG. 12, processing circuitry 210 may determine that noise impacting a sensedECAPs value has abated when T_(low-noise) 1316 has expired (1324).

Processing circuitry 210 may increase Ic 1314 until Ic 1314 reaches thedefault value of Ict 1306. The informed pulse current magnitude Ii 1312may remain at Iit 1308. To ensure the noise is gone, processingcircuitry 210 may start a confirmation timer, e.g. Tresume 1322, andonly restart the closed loop algorithm when Tresume 1322 expires (1326).In other words, in response to determining that Ic 1314 is at Ict 1306,the ECAP value is less than ETL 1304 and the confirmation timer Tresume1322 has expired, processing circuitry 210 may restart ERS (1328). Inother examples, (not shown in FIG. 13 ) processing circuitry 210 mayre-enable the closed loop algorithm rather than increasing the parametervalues for Ic 1314 and Ii 1312 until the values reach the default value.In other words, processing circuitry 210 may re-enable the closed-loopalgorithm such that IMD 200 may provide appropriate stimulation once thesystem determines that the noise source is gone.

FIG. 14 is a timing diagram illustrating an example of an attemptedrecovery for a suspended closed-loop algorithm, in accordance with oneor more techniques of this disclosure. As described above in relation toFIG. 13 , when processing circuitry 210 determines that the noise hasabated (1424), at the expiration of T_(low-noise) 1416, processingcircuitry 210 may increase Ic to the default value and start aconfirmation timer, e.g. Tresume 1322. At some time in the intervalbetween determining the noise has abated and the confirmation timer hasexpired, processing circuitry 210 may receive an indication from sensingcircuitry 206 that the ECAP value has exceeded ETH 1402 (1400).

In the example of FIG. 14 , Ic ramps toward Ict (1430) after processingcircuitry determines noise has abated (1424). However, noise againcouples to the sensing circuitry 206 of IMD 200 and processing circuitry210 controls Ic to decrease toward the minimum value of Ic=0 (1432). Inthis manner, processing circuitry 210 can react to any restart of noisewhen attempting to reestablish ERS. When processing circuitry 210 againdetermines that the noise has abated (1425) because the ECAP value 1400is less than ETH 1402 and ETL 1404, processing circuitry may again starta low noise timer, T_(low-noise) 1434. When T_(low-noise) 1434,processing circuitry 210 may re-attempt to ramp Ic toward Ict (1436). Toavoid under stimulation, the informed pulse amplitude Ii 1412 may remainat the default value Iit 1408. Once processing circuitry 210 ramps Icback to Ict, processing circuitry 210 can continue ERS as normal.

FIG. 15 is a flow diagram illustrating another example operation forsuspending and recovering a suspended closed-loop algorithm, inaccordance with one or more techniques of this disclosure. The exampleof FIG. 15 describes techniques illustrated by FIGS. 11-14 . Althoughprocessing circuitry 210 is described as performing the technique ofFIG. 15 , other circuitry of IMD and/or other devices may perform someor all of the technique in other examples.

Similar to FIG. 10 described above, processing circuitry 210 may receivean indication from sensing circuitry 206 whether the value of acharacteristic of sensed one or more sensed ECAPs 536 from FIG. 5 may beoutside of a target range (1500). When sensed ECAP values are within thetarget range (NO branch of 1500) processing circuitry 210 may hold thevalue of the set of parameter values, e.g. Ic and Ii, for the pluralityof pulses (1502). Processing circuitry 210 may continue to monitor ECAPvalues.

If the ECAP values are outside of the range, but not higher than theECAP high threshold (NO branch of 1504), processing circuitry 210 mayincrement Ic and Ii (1508) and continue to monitor ECAP values. In otherwords, if the ECAP values are outside of the range, but less than theECAP high threshold, the ECAP values must be less than the low ECAPthreshold.

When processing circuitry 210 determines that Ic=0, i.e. the minimumvalue of control pulse amplitude (YES branch of 1512), processingcircuitry may start a noise detection timer, Tdetect. If the ECAP valuesstay above ETH during Tdetect and Tdetect expires (YES branch of 1514),processing circuitry 210 may suspend ERS (1516) and begin to incrementonly Ii (1518) until Ii reach the default value, e.g. Iit 608 from FIG.6 (NO branch of 1520). When Ii reaches the default value (YES branch of1520), processing circuitry may hold Ii at the default values (1522) andmonitor ECAP values (NO branch of 1524). In this manner, IMD 200 maydeliver therapy to patient 105 of FIG. 1 and avoid under stimulationcaused by noise.

As described above in relation to FIGS. 12-14 , when processingcircuitry 210 receives an indication that the ECAP values are less thanETL, processing circuitry 210 may start T_(low-noise). When expires,processing circuitry may begin to increase Ic only (1530) because Ii isalready at the default value, Iit. As Ic is increasing, processingcircuitry 210 may continue to monitor the ECAP values (NO branch of1532). While the ECAP values remain less than or equal to ETL (YESbranch of 1534), processing circuitry 210 may continue to increase Ic(1530).

When Ic reaches the default value, Ict (YES branch of 1532), processingcircuitry 210 may start a confirmation timer Tresume, described above inrelation to FIGS. 13 and 14 . If the ECAP values exceed the ECAP highthreshold (NO branch of 1540) after the confirmation timer expires (YESbranch of 1536), processing circuitry 210 may decrement Ic (1538) backto the minimum value of IC, and continue to monitor the ECAP values. Ifthe ECAP values remain less than ETH (YES branch of 1540), thenprocessing circuitry 210 may restart the closed loop algorithm, e.g. ERS(1542).

FIG. 16 is a flow chart illustrating an example operation for managingpatient input while delivering electrical stimulation therapy, inaccordance with one or more techniques of this disclosure. As describedabove in relation to FIGS. 5 and 7 , it may be desirable to disablecertain programming commands from external programmer 150 while an IMDof this disclosure is responding to patient physiological signals or tonoise.

In example of FIG. 16 , the system may only increment therapy (e.g.increase amplitude) in response to a patient adjustment if the currentcontrol pulse and informed amplitude levels, Ic and Ii, areapproximately equal to the default levels, Ict and Iit, respectively. Asdescribed above in relation to FIGS. 5-15 , one or both of Ic and Ii,may approximately equal the default levels, Ict and Iit, when ERS isdisabled for a particular. One or both of Ic and Ii may approximatelyequal the default levels ERS was enabled, but not actively suppressingstimulation therapy levels due to high ECAP measurements. If Ic and/orIi are not at their default levels (e.g. being suppressed by the ERSalgorithm), then the system, may not increase the therapy and, moreimportantly, may not increase the default levels, according to thetechniques of this disclosure. As described above in relation to FIG. 2, the “system” and “processing circuitry 210” may refer to IMD 110 andIMD 200 alone, or in communication with external programmer 150.

In some examples, the patient may choose to decrement the therapyamplitude. Should the patient decrease therapy amplitude then the systemmay decrement the amplitude of the stimulation therapy being delivered.In addition, if the stimulation pulse amplitude (Ic or Ii) are at thedefault levels of Ict and Iit, respectively, then the request todecrement the therapy may also adjust the default amplitude level, Ictand Iit.

The techniques of this disclosure will therefore permit the system to beresponsive to patient requests, especially to decrement a therapy, butmay avoid unwanted conditions where a patient may increase a defaultstimulation level without a real-time increase in the therapy beingdelivered and perceived by the patient. In this manner, the techniquesof this disclosure may prevent issues of incorrect default leveladjustments above a comfortable level when a closed-loop therapyalgorithm has altered the stimulation levels away from the normaldefault stimulation levels for either a control pulse waveform or aninformed pulse waveform in the presence of noise or other sensing issue.Thus, a closed-loop responsive stimulation system of this disclosurethat includes the ability of patient adjustment needs may account forsituations when the system is responding to changes in physiologicalsignals or noise.

At the start (1600) of FIG. 16 , processing circuitry 210 may continueto monitor ECAP values and deliver electrical stimulation therapy asneeded while waiting for manual adjustment commands from a patientprogrammer (1602). In some examples, processing circuitry 210 mayreceive a command to increment one or both of the control pulseparameter, e.g. Ic, or the informed pulse parameter, e.g. Ii by aspecified amount. In the example of FIG. 16 , the specified increment(YES branch of 1604) is ΔI_(C/I), which indicates an increase in eitheror both of ΔIc or ΔIi.

Note that in the example of FIG. 16 , an increase in ΔIc or ΔIicorresponds to an increase in stimulation level. Similarly, an increasein other parameters for the control pulse or the informed pulse may alsoincrease the stimulation level. Some examples may include an increase involtage magnitude, an increase in duty cycle, an increase in pulse widthand similar parameters may increase the stimulation level. In otherexamples, requested changes to parameters may decrease the stimulationlevel. For example, selecting different electrodes, changing the outputimpedance and other parameter changes may decrease stimulation levels.The increase of block 1604 and decrease of block 1606 use changes inelectrical current amplitude as in an example of an increase or decreasein stimulation level and the description of FIG. 16 should not beinterpreted limited to just an increase or decrease in currentamplitude, but interpreted more broadly as an increase or decrease instimulation level.

In some examples, processing circuitry 210 may include a setting, e.g.stored at storage device 212, that disables any manual adjustments inthe control pulse parameters (NO branch of 1630). If changes to Ic aredisabled, then a command to increase Ic would result in no change(1634). In the example of FIG. 16 , at any time that processingcircuitry 210 rejects a request from the patient programmer, processingcircuitry 210 may communicate with the patient programmer, e.g.,external device 30, and provide an indication that the request has beenrejected. For example, at the NO branch of 1630, 1632, 1644, 1608 and soon.

Processing circuitry 210 may be further configured to disable any manualadjustments in the informed pulse parameters (NO branch of 1640). Ifchanges to Ii are disabled, then a command to increase Ii would resultin no change (1642) and processing circuitry may continue to monitor formanual adjustments (1602).

In other examples, processing circuitry 210 may enable adjustments to Ic(YES branch of 1630) and processing circuitry 210 may determine whetherthe set of parameter values for the electrical stimulation therapy isapproximately equal to a default set of parameter values, e.g., whetherIc≥I_(CT)±δI_(CT). When Ic is outside the predetermined range of therespective default parameter value, e.g. differs from Ict by more than±δI_(CT), (NO branch of 1632), then processing circuitry 210 may notincrement Ic (1634). When Ic is with the predetermined range (YES branchof 1632), processing circuitry 210 may increment Ic by ΔIc (1636) andchange the default value Ict to the new value of Ic (1638). Said anotherway, processing circuitry 210, may first determine that the value of theparameter defining the electrical stimulation therapy is not within atolerance, ±δI_(CT), of a default parameter before rejecting the requestto change the parameter. The tolerance, ±δI_(CT), is a small value,compared to the default value, that may be zero.

In examples in which processing circuitry 210 may enable adjustments toIi (YES branch of 1640) and processing circuitry 210 may determinewhether the set of parameter values for the electrical stimulationtherapy is approximately equal to a default set of parameter values,e.g., whether I_(I)≥I_(IT)±δI_(IT). When Ii is outside the predeterminedrange of the respective default parameter value, e.g. differs from Iitby more than ±δI_(IT), (NO branch of 1644), then processing circuitry210 may not increment Ii (1642). When Ii is with the predetermined range(YES branch of 1644), processing circuitry 210 may increment Ii by ΔIi(1646) and change the default value Iit to the new value of Ii (1688).

In other examples, processing circuitry may receive a decrement commandfrom external programmer 150 (NO branch of 1604 and YES branch of 1606).

Processing circuitry 210 may be configured to disable any manualadjustments in the control pulse parameters (NO branch of 1608). Ifchanges to Ic are disabled, then a command to decrease Ic would resultin no change (1616).

Processing circuitry 210 may be further configured to disable any manualadjustments in the informed pulse parameters (NO branch of 1618). Ifchanges to Ii are disabled, then a command to decrease Ii would resultin no change (1626) and processing circuitry may continue to monitor formanual adjustments (1602).

In other examples, processing circuitry 210 may be configured to enableadjustments to Ic (YES branch of 1608) and processing circuitry 210 maydetermine whether the set of parameter values for the electricalstimulation therapy is approximately equal to a default set of parametervalues, e.g., whether I_(C)≥I_(CT)±δI_(CT). When Ic is outside thepredetermined range of the respective default parameter value, e.g.differs from Ict by more than ±δI_(CT), (NO branch of 1610), then, incontrast to the increment command, processing circuitry 210 maydecrement Ic by ΔIc, i.e. Ic=Ic−ΔIc (1612), but make no change to thedefault value Ict. In other examples, when Ic is with the predeterminedrange (YES branch of 1610), processing circuitry 210 may decrement bothIc by ΔIc (1612) and change the default value Ict to the new value ofIc, i.e. Ict=Ict−ΔIc (1614).

In examples in which processing circuitry 210 may enable adjustments toIi (YES branch of 1618) and processing circuitry 210 may determinewhether the set of parameter values for the electrical stimulationtherapy is approximately equal to a default set of parameter values,e.g., whether I_(I)≥I_(IT)±δI_(IT). When Ii is outside the predeterminedrange of the respective default parameter value, e.g. differs from Et bymore than ±δI_(IT), (NO branch of 1620), in contrast to the incrementcommand, processing circuitry 210 may decrement Ii by ΔIi, i.e.Ii=Ii−ΔIi (1622), but make no change to the default value Et. In otherexamples, when Ii is with the predetermined range (YES branch of 1620),processing circuitry 210 may decrement both Ii by ΔIi (1622) and changethe default value Et to the new value of Ii, i.e. Iit=Iit−ΔIi (1624).

In one or more examples, the functions described above may beimplemented in hardware, software, firmware, or any combination thereof.For example, the various components of FIGS. 1 and 2 , such asprocessing circuitry 210, sensing circuitry 206, and communicationcircuitry 208 may be implemented in hardware, software, firmware, or anycombination thereof. If implemented in software, the functions may bestored on or transmitted over, as one or more instructions or code, acomputer-readable medium and executed by a hardware-based processingunit. Computer-readable media, such as storage device 212, may includecomputer-readable storage media, which corresponds to a tangible mediumsuch as data storage media, or communication media including any mediumthat facilitates transfer of a computer program from one place toanother, e.g., according to a communication protocol. In this manner,computer-readable media generally may correspond to (1) tangiblecomputer-readable storage media which is non-transitory or (2) acommunication medium such as a signal or carrier wave. Data storagemedia may be any available media that can be accessed by one or morecomputers or one or more processors to retrieve instructions, codeand/or data structures for implementation of the techniques described inthis disclosure. A computer program product may include acomputer-readable medium. The term “non-transitory” may indicate thatthe storage medium is not embodied in a carrier wave or a propagatedsignal. In certain examples, a non-transitory storage medium may storedata that can, over time, change (e.g., in RAM or cache).

By way of example, and not limitation, such computer-readable storagemedia, such as storage device 212, may include random access memory(RAM), read only memory (ROM), programmable read only memory (PROM),erasable programmable read only memory (EPROM), electronically erasableprogrammable read only memory (EEPROM), flash memory, a hard disk, acompact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media,optical media, or other computer readable media. In some examples, anarticle of manufacture may include one or more computer-readable storagemedia.

Also, any connection is properly termed a computer-readable medium. Forexample, if instructions are transmitted from a website, server, orother remote source using a coaxial cable, fiber optic cable, twistedpair, digital subscriber line (DSL), or wireless technologies such asinfrared, radio, and microwave, then the coaxial cable, fiber opticcable, twisted pair, DSL, or wireless technologies such as infrared,radio, and microwave are included in the definition of medium. It shouldbe understood, however, that computer-readable storage media and datastorage media do not include connections, carrier waves, signals, orother transient media, but are instead directed to non-transient,tangible storage media. Combinations of the above should also beincluded within the scope of computer-readable media.

Instructions may be executed by one or more processors, such as one ormore DSPs, general purpose microprocessors, ASICs, FPGAs, or otherequivalent integrated or discrete logic circuitry. Accordingly, the term“processor,” as used herein, such as processing circuitry 210, may referto any of the foregoing structure or any other structure suitable forimplementation of the techniques described herein. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

The techniques of this disclosure may be implemented in a wide varietyof devices or apparatuses, including, an integrated circuit (IC) or aset of ICs (e.g., a chip set). Various components, modules, or units aredescribed in this disclosure to emphasize functional aspects of devicesconfigured to perform the disclosed techniques, but do not necessarilyrequire realization by different hardware units. Rather, as describedabove, various units may be combined in a hardware unit or provided by acollection of interoperative hardware units, including one or moreprocessors as described above, in conjunction with suitable softwareand/or firmware.

Example 1: A method that includes receiving information indicative of asensed evoked compound action potential (ECAP) signal; determining avalue of a characteristic of the ECAP signal based on the information,wherein the ECAP signal is elicited by a respective stimulation pulse ofa plurality of stimulation pulses; executing a closed loop policy thatadjusts, based on the value of the characteristic of the ECAP signal, avalue of a parameter that at least partially defines stimulationtherapy; determining that the value of the characteristic of the ECAPsignal is outside of an expected range; and responsive to determiningthat the value of the characteristic of the ECAP signal is outside ofthe expected range, disabling the closed loop policy.

Example 2: The method of example 1, wherein the value of the parameteris a first value, wherein a set of values for the parameter comprises athreshold value, and wherein the method further comprises: responsive toadjusting the first value to the threshold value based on the closedloop policy, starting a noise detection timer; determining that thenoise detection timer has expired; and responsive to determining thatthe noise detection timer has expired, determining that the value of thecharacteristic of the ECAP signal remains outside of the expected range;and responsive to determining that the value of the characteristic ofthe ECAP signal remains outside of the expected range, disabling theclosed-loop policy.

Example 3: The method of example 2, wherein the threshold value of theparameter of the respective stimulation pulses comprises a minimum valuefor the parameter.

Example 4: The method of example 2, wherein the plurality of pulsescomprises a plurality of control pulses and a plurality of informedpulses, wherein the respective stimulation pulses comprise respectivecontrol pulses of the plurality of control pulses, wherein receivinginformation indicative of a ECAP signal comprises sensing a respectiveECAP signal after a respective control pulse of the plurality of controlpulses, wherein an informed pulse of the plurality of informed pulses isdefined by one or more parameters based on a respective ECAP signalelicited from a respective control pulse while executing the closed looppolicy; wherein the expected range of the value of the characteristiccomprises an ECAP high threshold (ETH) and an ECAP low threshold (ETL),and wherein the method further comprises: responsive to the value of thecharacteristic of the ECAP signal greater than the ECAP high threshold,incrementally adjusting: a respective value of the parameter definingthe plurality of respective control pulses from a first control pulsevalue toward a second control pulse value; and a respective value of theparameter defining the plurality of respective informed pulses from afirst informed pulse value toward a second informed pulse value.

Example 5: The method of example 4, further that includes responsive todisabling the closed loop policy, adjusting, by the processingcircuitry, informed pulse parameter values back to the first informedpulse value, and measuring, by the sensing circuitry, the respectiveECAP signal after the respective control pulse, wherein the processingcircuitry makes no adjustments to informed pulse parameter values norcontrol pulse parameter values based on the measured respective ECAPsignal while the closed loop policy is disabled.

Example 6: The method of example 4, further comprising, responsive tosensing, by the sensing circuitry, that the value of the characteristicof the measured respective ECAP signal is less than the ECAP highthreshold, starting, by the processing circuitry a low-noise timer.

Example 7: The method of example 6, further comprising, responsive todetermining, by the processing circuitry, that the low-noise timer hasexpired, enabling, by the processing circuitry, the closed-loop policy.

Example 8: The method of example 5, wherein the first informed pulsevalue of the parameter is a control pulse parameter default value,wherein the second control pulse value is less than or equal to thedefault value, and wherein the control pulse parameter is set to thesecond control pulse value, the method further comprising, in responseto in response to receiving an indication from the sensing circuitrythat the value of the characteristic of the measured respective ECAPsignal is less than the ECAP low threshold, start a low-noise timer;responsive to determining that the low-noise timer has expired,adjusting, by the processing circuitry, the control pulse parametervalues from the second control pulse value to the default value.

Example 9: The method of example 8, further that includes responsive tosetting the control pulse parameter values to the default value,starting, by the processing circuitry, a confirmation timer, andresponsive to determining that the confirmation timer has expired,enabling, by the processing circuitry, the closed-loop policy.

Example 10: The method of example 8, further that includes responsive tosensing, by the sensing circuitry, that the value of the characteristicof the measured respective ECAP signal is greater than the ECAP highthreshold, reducing, by the processing circuitry, the respective valueof the parameter for the plurality of respective control pulses; and therespective value of the parameter for the plurality of respectiveinformed pulses.

Example 11: The method of example 10, further that includes responsiveto determining that the low-noise timer has expired, adjusting, by theprocessing circuitry, control pulse value from the second control valueto the default control pulse value, responsive to setting the controlpulse parameter values to the default control pulse value, starting, bythe processing circuitry, a confirmation timer, and responsive todetermining that the confirmation timer has expired, enabling, by theprocessing circuitry, the closed-loop policy.

Example 12: The method of example 1, further comprising controlling thestimulation generation circuitry to deliver electrical stimulationtherapy according to: the closed loop policy, or user input.

Example 13: A medical device comprising processing circuitry configuredto: receive information indicative of a sensed evoked compound actionpotential (ECAP) signal determine a value of a characteristic of theECAP signal based on the information, wherein the ECAP signal iselicited by respective stimulation pulses of a plurality of pulses;determine whether a value of a characteristic of the ECAP signal isoutside of an expected range; execute a closed loop policy, wherein theclosed loop policy adjusts a value of a parameter that at leastpartially defines stimulation therapy, based on the value of thecharacteristic of the ECAP signal; and responsive to determining thatthe value of the characteristic of the ECAP signal is outside of theexpected range, disable the closed-loop policy.

Example 14: The medical device of example 13, wherein the value of theparameter is a first value, wherein a set of values for the parametercomprises a threshold value; the processing circuitry further configuredto: responsive to adjusting the value of the parameter from the firstvalue to the threshold value, starting, a noise detection timer;responsive to determining that the noise detection timer has expired,and that the value of the characteristic of the ECAP signal is stilloutside of the expected range, disable the closed-loop policy.

Example 15: The medical device of example 14, wherein the thresholdvalue of the parameter of the respective stimulation pulses comprises aminimum value for the parameter.

Example 16: The medical device of example 15: wherein the plurality ofpulses comprises a plurality of control pulses and a plurality ofinformed pulses, wherein the respective stimulation pulses compriserespective control pulses of the plurality of control pulses, whereinreceiving information indicative of a ECAP signal comprises sensing arespective ECAP signal after a respective control pulse of the pluralityof control pulses, wherein an informed pulse of the plurality ofinformed pulses is defined by one or more parameters based on arespective ECAP signal elicited from a respective control pulse, whereinthe expected range of the value of the characteristic comprises an ECAPhigh threshold (ETH) and an ECAP low threshold (ETL), the processingcircuitry further configured to, responsive to the value of thecharacteristic of the ECAP signal greater than the ECAP high threshold,incrementally adjusting: a respective value of the parameter for theplurality of respective control pulses from a first control pulse valuetoward a second control pulse value; and a respective value of theparameter for the plurality of respective informed pulses from a firstinformed pulse value toward a second informed pulse value.

Example 17: The medical device of example 16, wherein the processingcircuitry is further configured to: responsive to disabling the closedloop policy, adjust the informed pulse parameter values back to thefirst informed pulse values, and cause the sensing circuitry to measurethe respective ECAP signal after the respective control pulse, whereinthe processing circuitry makes no adjustments to the informed pulseparameter values nor the control pulse parameter values based on themeasured respective ECAP signal while the closed loop policy isdisabled.

Example 18: The medical device of example 17, wherein the processingcircuitry further configured to, responsive to receiving an indicationfrom the sensing circuitry that the value of the characteristic of themeasured respective ECAP signal is less than the ECAP high threshold,start a low-noise timer.

Example 19: The medical device of example 18, wherein the processingcircuitry is further configured to, responsive to determining that thelow-noise timer has expired, enable the closed-loop policy.

Example 20: The medical device of example 16, wherein the first informedpulse value of the parameter is a control pulse parameter default value,wherein the second control pulse value is less than or equal to thedefault value, and wherein the control pulse parameter is set to thesecond control pulse value, wherein the processing circuitry furtherconfigured to: responsive to receiving an indication from the sensingcircuitry that the value of the characteristic of the measuredrespective ECAP signal is less than the ECAP low threshold, start alow-noise timer; and responsive to determining that the low-noise timerhas expired, adjust the control pulse parameter values from the secondcontrol pulse value to the default control pulse value.

Example 21: The medical device of example 20, wherein the processingcircuitry is further configured to, responsive to setting the controlpulse parameter values to the default control pulse value, start aconfirmation timer, and responsive to determining that the confirmationtimer has expired, enable the closed-loop policy.

Example 22: The medical device of example 20, wherein the processingcircuitry is further configured to, responsive to receiving anindication from the sensing circuitry, that the value of thecharacteristic of the measured respective ECAP signal is greater thanthe ECAP high threshold, reducing the respective value of the parameterfor the plurality of respective control pulses.

Example 23: The medical device of example 22, wherein the processingcircuitry is further configured to, responsive to determining that thelow-noise timer has expired, adjust the control pulse parameter valuesfrom the second control pulse value to the default control pulse value,responsive to setting the control pulse parameter values to the defaultcontrol pulse value, start a confirmation timer, and responsive todetermining that the confirmation timer has expired, enable theclosed-loop policy.

Example 24: The medical device of example 13, wherein the processingcircuitry is further configured to control the stimulation generationcircuitry to deliver electrical stimulation therapy according to: theclosed loop policy, or user input.

Example 25: A computer-readable medium comprising instructions forcausing programmable processor processing circuitry to: receiveinformation indicative of a sensed evoked compound action potential(ECAP) signal determine a value of a characteristic of the ECAP signalbased on the information, wherein the ECAP signal is elicited byrespective stimulation pulses of a plurality of pulses; determinewhether a value of a characteristic of the ECAP signal is outside of anexpected range; execute a closed loop policy, wherein the closed looppolicy adjusts a value of a parameter that at least partially definesstimulation therapy, based on the value of the characteristic of theECAP signal; and responsive to determining that the value of thecharacteristic of the ECAP signal is outside of the expected range,disable the closed-loop policy.

Example 26: A method that includes delivering, by stimulation generationcircuitry of a medical device, electrical stimulation therapy to apatient, the electrical stimulation therapy comprising a plurality ofpulses defined by a set of parameters; receiving, by processingcircuitry of the medical device, a request from an external programmerto change a value of a parameter defining the plurality of pulses,wherein the external programmer is external to the medical device;determining, by the processing circuitry, that the requested change tothe parameter is a request to increase the value of the parameterdefining the plurality of pulses; determining, by the processingcircuitry, that a control policy executed by the processing circuitry isdetermining values of the parameter that defines the electricalstimulation therapy; responsive to determining that the control policyis determining values of the parameter that defines the electricalstimulation therapy, rejecting, by the processing circuitry, the requestto change the value of the parameter.

Example 27: The method of example 26, wherein determining that thecontrol policy is determining values of the parameter that defines theelectrical stimulation therapy comprises: determining, by the processingcircuitry, that the value of the parameter defining the electricalstimulation therapy is not within a tolerance of a default parameter;responsive to determining that the value of the parameter defining theelectrical stimulation therapy is not within the tolerance of thedefault parameter, rejecting, by the processing circuitry the request toincrease the value of the parameter.

Example 28: The method of any combination of examples 26-27, wherein thecommand from the external programmer is a is a first command, the methodfurther that includes receiving, from the external programmer, a secondcommand to change the value of the parameter defining the plurality ofpulses; determining, by the processing circuitry, that the requestedchange to the parameter in the second command is also a request toincrease the value of the parameter defining the plurality of pulses;responsive to determining that the value of the parameter defining theelectrical stimulation therapy is within the tolerance of the defaultparameter, increasing, by the processing circuitry both the parameterand the default parameter based on the command from the externalprogrammer.

Example 29: The method of any combination of examples 26-28, wherein thecommand from the external programmer is a is a first command, the methodfurther that includes receiving, from the external programmer, a secondcommand to change the value of the parameter defining the plurality ofpulses; determining, by the processing circuitry, that the requestedchange to the parameter in the second command is a request to decreasethe value of the parameter defining the plurality of pulses; responsiveto determining that the requested change is a request to decrease thevalue of the parameter, changing, by the processing circuitry both theparameter and a default value of the parameter.

Example 30: The method of any combination of examples 26-29, furthercomprising, responsive to determining that the requested change is arequest to decrease the value of the parameter, and before changing boththe parameter and the default value of the parameter; determining thatthe value of the parameter defining the electrical stimulation therapyis within the tolerance of the default parameter; responsive todetermining that the value of the parameter defining the electricalstimulation therapy is within a tolerance of the default parameter,changing, by the processing circuitry both the parameter and the defaultvalue of the parameter.

Example 31: The method of any combination of examples 26-30, wherein theparameter is an electrical current amplitude.

Example 32: The method of any combination of examples 26-31, wherein theset of parameters comprises the current amplitude that at leastpartially defines an informed pulse, and wherein the method furthercomprises: controlling the stimulation generation circuitry to deliver acontrol pulse configured to elicit a detectable evoked compound actionpotentials (ECAP) signal; receiving the ECAP signal; and executing thecontrol policy to determine, based on the ECAP signal elicited by thedelivered control pulse, an updated value of the current amplitude thatat least partially defines a subsequent informed pulse and an updatedvalue of a current amplitude that at least partially defines asubsequent control pulse.

Example 33: The method of any combination of examples 26-32, furthercomprising, outputting, by the processing circuitry of the medicaldevice, an indication to the external programmer that the processingcircuitry has rejected the request to change the value of the parameter.

Example 34: A medical device that includes stimulation generationcircuitry configured to deliver electrical stimulation therapy to apatient, the electrical stimulation therapy comprising a plurality ofpulses defined by a set of parameters; and processing circuitryconfigured to: receive a command from an external programmer (1602) tochange a value of a parameter defining the plurality of pulses, whereinthe external programmer is external to the medical device; determinethat the requested change to the parameter is a request to increase thevalue of the parameter defining the plurality of pulses; determiningthat a control policy executed by the processing circuitry isdetermining values of the parameter that defines the electricalstimulation therapy responsive to determining that the control policy isdetermining values of the parameter that defines the electricalstimulation therapy, reject the request to change the value of theparameter.

Example 35: The medical device of example 34, wherein to determine thatthe control policy is determining values of the parameter that definesthe electrical stimulation therapy comprises the processing circuitryconfigured to: determine that the value of the parameter defining theelectrical stimulation therapy is with the tolerance of a defaultparameter; responsive to determining that the value of the parameterdefining the electrical stimulation therapy is not within the toleranceof the default parameter, reject the request to change to the parameterto increase the value of the parameter.

Example 36: The medical device of any combination of examples 34-35,wherein the parameter value is an electrical current amplitude.

Example 37: The medical device of any combination of examples 34-36,wherein the command from the external programmer is a is a firstcommand, and wherein the processing circuitry is further configured to:receive a second command to change the value of the parameter definingthe plurality of pulses; determine that the requested change to theparameter in the second command is also a request to increase the valueof the parameter defining the plurality of pulses; responsive todetermining that the value of the parameter defining the electricalstimulation therapy is within the tolerance of the default parameter,increase both the parameter and the default parameter based on thecommand from the external programmer.

Example 38: The medical device of any combination of examples 34-37,wherein the command from the external programmer is a is a firstcommand, and wherein the processing circuitry is further configured to:receive a second command from the external programmer to change thevalue of the parameter defining the plurality of pulses; determine thatthe requested change to the parameter in the second command is a requestto decrease the value of the parameter defining the plurality of pulses;responsive to determining that the requested change is a request todecrease the value of the parameter, change both the parameter and adefault value of the parameter.

Example 39: The medical device of any combination of examples 34-38,wherein the set of parameters comprises the current amplitude that atleast partially defines an informed pulse, and wherein the methodfurther comprises: controlling the stimulation generation circuitry todeliver a control pulse configured to elicit a detectable evokedcompound action potentials (ECAP) signal; receiving the ECAP signal; andexecuting the control policy to determine, based on the ECAP signalelicited by the delivered control pulse, an updated value of the currentamplitude that at least partially defines a subsequent informed pulseand an updated value of a current amplitude that at least partiallydefines a subsequent control pulse.

Example 40: The medical device of any combination of examples 34-39,wherein the processing circuitry of the medical device is configured tooutput an indication to the external programmer that the processingcircuitry has rejected the request to change the value of the parameter.

Example 41: A computer-readable medium comprising instructions forcausing a programmable processor of a medical device to: causestimulation generation circuitry of the medical device to deliverelectrical stimulation therapy to a patient, the electrical stimulationtherapy comprising a plurality of pulses defined by a set of parameters;receive of the medical device, a command from an external programmer tochange a value of a parameter defining the plurality of pulses, whereinthe external programmer is external to the medical device; determinethat the requested change to the parameter is a request to increase thevalue of the parameter defining the plurality of pulses; determine thata control policy executed by the processing circuitry is determiningvalues of the parameter that defines the electrical stimulation therapy;responsive to determining that the control policy is determining valuesof the parameter that defines the electrical stimulation therapy, rejectthe request to change the value of the parameter.

Example 42: The computer-readable medium of example 41, whereindetermining that the control policy is determining values of theparameter that defines the electrical stimulation therapy comprises:determining, by the processing circuitry, that the value of theparameter defining the electrical stimulation therapy is not within atolerance of a default parameter; responsive to determining that thevalue of the parameter defining the electrical stimulation therapy isnot within the tolerance of the default parameter, rejecting, by theprocessing circuitry the request to increase the value of the parameter.

Example 43: The computer-readable medium of any combination of examples41-42, wherein the command from the external programmer is a is a firstcommand, the method further that includes receiving, from the externalprogrammer, a second command to change the value of the parameterdefining the plurality of pulses; determining, by the processingcircuitry, that the requested change to the parameter in the secondcommand is also a request to increase the value of the parameterdefining the plurality of pulses; responsive to determining that thevalue of the parameter defining the electrical stimulation therapy iswithin the tolerance of the default parameter, increasing, by theprocessing circuitry both the parameter and the default parameter basedon the command from the external programmer.

Example 44: The computer-readable medium of any combination of examples41-43, wherein the command from the external programmer is a is a firstcommand, the method further that includes receiving, from the externalprogrammer, a second command to change the value of the parameterdefining the plurality of pulses; determining, by the processingcircuitry, that the requested change to the parameter in the secondcommand is a request to decrease the value of the parameter defining theplurality of pulses; responsive to determining that the requested changeis a request to decrease the value of the parameter, changing, by theprocessing circuitry both the parameter and the default value of theparameter.

Example 45: The computer-readable medium of any combination of examples41-44, wherein the parameter is an electrical current amplitude.

Various examples of the disclosure have been described. These and otherexamples are within the scope of the following claims.

What is claimed is:
 1. A method comprising: delivering, by stimulationgeneration circuitry of a medical device, electrical stimulation therapyto a patient, the electrical stimulation therapy comprising a pluralityof pulses defined by a set of parameters; receiving, by processingcircuitry of the medical device, physiological signals sensed from thepatient; executing, by the processing circuitry, a control policyconfigured to adjust at least one parameter of the set of parameters inresponse to the physiological signals; receiving, by the processingcircuitry of the medical device, a request from an external programmerto change a stimulation level of the electrical stimulation therapy at afirst time, wherein the external programmer is external to the medicaldevice; determining, by the processing circuitry, that the request is toincrease the stimulation level; and determining that the at least oneparameter is being adjusted at the first time according to the controlpolicy; responsive to determining that the at least one parameter isbeing adjusted according to the control policy, rejecting, by theprocessing circuitry, the request to change the stimulation level. 2.The method of claim 1, wherein determining that the at least oneparameter is being adjusted according to the control policy comprisesdetermining, by the processing circuitry, whether a value of a firstparameter of the set of parameters defining the electrical stimulationtherapy is within a tolerance of a respective default parameter value,and wherein rejecting the request comprises, responsive to determiningthat the value of the first parameter is not within the tolerance of therespective default parameter, rejecting, by the processing circuitry,the request to increase the stimulation level.
 3. The method of claim 2,wherein the request from the external programmer is a is a firstrequest, the method further comprising: receiving, from the externalprogrammer, a second request, different from the first request, tochange the value of the stimulation level of the electrical stimulationtherapy; determining, by the processing circuitry that the value of thefirst parameter is within the tolerance of the respective defaultparameter value; determining, by the processing circuitry, that thesecond request is also to increase the stimulation level; responsive todetermining that the value of the first parameter is within thetolerance of the respective default parameter, determining, by theprocessing circuitry, that the at least one parameter is not beingadjusted during the second request, and increasing, by the processingcircuitry both the stimulation level and the respective defaultparameter based on the second request to increase the stimulation levelfrom the external programmer.
 4. The method of claim 2, wherein therequest from the external programmer is a first request, the methodfurther comprising: receiving, from the external programmer, a secondrequest different from the first request to change the stimulationlevel; determining, by the processing circuitry, that the second requestis to decrease the stimulation level; responsive to determining that therequested change is a request to decrease the stimulation level,changing, by the processing circuitry the stimulation level.
 5. Themethod of claim 4, further comprising: responsive to determining thatthe requested change is a request to decrease the value of theparameter, and before changing the stimulation level; responsive todetermining that the value of the first parameter is within thetolerance of the respective default parameter, determining, by theprocessing circuitry, that the at least one parameter is not beingadjusted, and; responsive to determining that the value of the firstparameter is not being adjusted, changing, by the processing circuitryboth the stimulation level and the respective default value of theparameter.
 6. The method of claim 2, wherein the first parameter is anelectrical current amplitude.
 7. The method of claim 6, wherein the setof parameters at least partially defines an informed pulse and a controlpulse, wherein the physiological signals comprise an evoked compoundaction potential (ECAP) signal, and wherein the method furthercomprises: controlling the stimulation generation circuitry to deliver acontrol pulse configured to elicit a detectable ECAP signal; receivingthe ECAP signal; and executing the control policy to determine, based onthe ECAP signal elicited by the delivered control pulse, one or moreupdated values of the set of parameters that at least partially definesa subsequent informed pulse and one or more updated values of the set ofparameters that at least partially defines a subsequent control pulse.8. The method of claim 1, further comprising, responsive to rejectingthe request to change the stimulation level, outputting, by theprocessing circuitry of the medical device, an indication to theexternal programmer that the processing circuitry has rejected therequest to change the stimulation level.
 9. A medical device comprising:stimulation generation circuitry configured to deliver electricalstimulation therapy to a patient, the electrical stimulation therapycomprising a plurality of pulses defined by a set of parameters; andprocessing circuitry configured to: control the stimulation generationcircuitry; receive physiological signals sensed from the patient;execute a control policy configured to adjust at least one parameter ofparameters in response to the physiological signals; receive a requestfrom an external programmer to change a stimulation level of theelectrical stimulation therapy at a first time, wherein the externalprogrammer is external to the medical device; determine that the requestis to increase the stimulation level; determine that the control policyexecuted by the processing circuitry is adjusting, at the first time, atleast one parameter of the set of parameters, responsive to determiningthat the control policy is adjusting at least one parameter, reject therequest to change the stimulation level.
 10. The medical device of claim9, wherein to determine that the control policy is adjusting the atleast one parameter the processing circuitry is configured to determinewhether a value of a first parameter of the set of parameters definingthe electrical stimulation therapy is with a tolerance of a respectivedefault parameter value, and wherein rejecting the request comprises,responsive to determining that the value of the first parameter definingthe electrical stimulation therapy is not within the tolerance of therespective default parameter, reject the request to increase thestimulation level.
 11. The medical device of claim 10, wherein the firstparameter is an electrical current amplitude.
 12. The medical device ofclaim 10, wherein the request from the external programmer is a firstrequest, and wherein the processing circuitry is further configured to:receive a second request different from the first request to change thestimulation level; determine that the second request is also to increasethe stimulation level; responsive to determining that the value of thefirst parameter is within the tolerance of the respective defaultparameter, determine that the at least one parameter is not beingadjusted, and increase both the stimulation level and the defaultparameter based on the second request to increase the stimulation levelfrom the external programmer.
 13. The medical device of claim 10,wherein the request from the external programmer is a is a firstrequest, and wherein the processing circuitry is further configured to:receive a second request different from the first request from theexternal programmer to change the stimulation level; determine that thesecond request is to decrease the stimulation level; responsive todetermining that the second request is to decrease the stimulationlevel, change the stimulation level.
 14. The medical device of claim 9,wherein the set of parameters at least partially defines an informedpulse and a control pulse, wherein the physiological signals comprise anevoked compound action potential (ECAP) signal, and wherein theprocessing circuitry is further configured to: control the stimulationgeneration circuitry to deliver a control pulse configured to elicit adetectable ECAP signal; receive the ECAP signal; and execute the controlpolicy to determine, based on the ECAP signal elicited by the deliveredcontrol pulse, one or more updated values of the set of parameters thatat least partially defines a subsequent informed pulse and one or moreupdated values of the set of parameters that at least partially definesa subsequent control pulse.
 15. The medical device of claim 9, wherein,responsive to rejecting the request to change the stimulation level, theprocessing circuitry of the medical device is further configured tooutput an indication to the external programmer that the processingcircuitry has rejected the request to change the stimulation level. 16.A non-transitory computer-readable storage medium comprisinginstructions for causing a programmable processor of a medical deviceto: cause stimulation generation circuitry of the medical device todeliver electrical stimulation therapy to a patient, the electricalstimulation therapy comprising a plurality of pulses defined by a set ofparameters; receive physiological signals sensed from the patient;execute a control policy configured to adjust at least one parameter ofthe set of parameters in response to the physiological signals; receivea request from an external programmer to change a stimulation level ofthe electrical stimulation therapy at a first time wherein the externalprogrammer is external to the medical device; determine that therequested change is a request to increase the stimulation level;determine that the control policy executed by the processing circuitryis adjusting, at the first time, at least one parameter of the set ofparameters that define the electrical stimulation therapy; responsive todetermining that the at least one parameter is being adjusted accordingto the control policy, reject the request to change the stimulationlevel.
 17. The non-transitory computer-readable storage medium of claim16, wherein to determine that the at least one parameter is beingadjusted according to the control policy comprises determining whether avalue of a first parameter defining the electrical stimulation therapyis within a tolerance of a respective default parameter value, andwherein rejecting the request comprises, responsive to determining thatthe value of the first parameter is not within the tolerance of therespective default parameter value, reject the request to increase thestimulation level.
 18. The non-transitory computer-readable storagemedium of claim 17, wherein the request from the external programmer isa first request, the instructions further causing the programmableprocessor of the medical device to: receive, from the externalprogrammer, a second request different from the first request to changethe stimulation level of the electrical stimulation therapy; determinethat the value of the first parameter is within the tolerance of therespective default parameter value; determine that the second request isalso a request to increase the stimulation level; responsive todetermining that the value of the first parameter defining theelectrical stimulation therapy is within the tolerance of the respectivedefault parameter value, determine that the at least one parameter isnot being adjusted, and increase both the stimulation level and therespective default parameter value based on the second request toincrease the stimulation level from the external programmer.
 19. Thenon-transitory computer-readable storage medium of claim 17, wherein therequest from the external programmer is a first request, theinstructions further causing the programmable processor of the medicaldevice to: receive, from the external programmer, a second requestdifferent from the first request to change the stimulation level of theelectrical stimulation therapy; determine that the second request is todecrease the stimulation level; responsive to determining that thesecond request is a request to decrease the value of the stimulationlevel, change the stimulation level based on the request from theexternal programmer.
 20. The non-transitory computer-readable storagemedium of claim 17, wherein to change a stimulation level of theelectrical stimulation therapy comprises a change to one or more of anelectrical current amplitude, a pulse width, a voltage amplitude, anoutput impedance, a selected electrode, and a duty cycle.